Does tretinoin expire? Dates and storage

Yes, tretinoin expires. The FDA has required an expiration date on prescription medicines since 1979, and its advice is plain: "If your medicine has expired, do not use it." The date marks the end of the period in which the drug is known to stay stable when it is stored the way its label says. This guide explains the date, the storage line on each tretinoin label, and what heat and light do to the drug. For the drug itself, see the tretinoin guide.

Skinli gives general education and is not a doctor. No source read for this hub measured how much tretinoin is left in a tube after its date, so this page gives no number of extra months. Your pharmacist can read the date on your tube and answer questions about your own product.

What the expiration date on a tube means

The FDA defines the date in two sentences. "Drug expiration dates reflect the time period during which the product is known to remain stable", and stable means "it retains its strength, quality, and purity when it is stored according to its labeled storage conditions."

The maker has to prove the date. The FDA says its "regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions". Stability testing measures whether a product keeps its strength, quality and purity over time.

The rule dates from 1979. "In 1979, the U.S. Food and Drug Administration began requiring an expiration date on prescription and over-the counter medicines." The FDA says the date is "printed on the label or stamped onto the bottle or carton, sometimes following "EXP."" On a tretinoin product, that means the carton or the container.

The date holds only if the tube is stored as its label says. The FDA says: "Drugs held by consumers may have been stored under varied conditions after entering the market." A tube that sat in heat or in a damp room may have changed before its date.

Can you use expired tretinoin?

The FDA's answer for every medicine is no. "Once the expiration date has passed there is no guarantee that the medicine will be safe and effective. If your medicine has expired, do not use it."

It gives two reasons, and both apply to drugs in general:

What can change	The FDA's words
Strength	"it might not provide the patient with the intended benefit because it has a lower strength than intended."
Chemical makeup	"when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects."

The FDA sums up the risk in one line: "Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength."

For tretinoin in particular, the sources say nothing more. No label, FDA page or study read for this hub tested tubes after their date, so these sources cannot say how weak an old tube is or whether it irritates more. The FDA's instruction is to stop using it, which means asking for a new supply.

A weak tube also makes results hard to judge. The generic tretinoin label says that "more than 6 weeks of therapy may be required before definite beneficial effects are seen." If the tube holds less drug than its label states, you cannot tell whether a slow result comes from your skin or from the tube. The guide on how long tretinoin takes to work covers the timeline.

After opening, and tubes that were never opened

People ask whether a new, shorter period starts when the tube is opened. No tretinoin label read for this hub gives a period after opening, so the printed date is the only date the sources support.

The same holds for an unopened tube. It can be used until the printed date, as long as it was stored the way the label says. No label read for this hub states a shelf life as a number of months or years.

The generic cream leaflet gives two storage lines that apply after opening: "Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C)."

How each tretinoin label says to store it

The storage line differs by product. These are the lines on the labels published on DailyMed, the US National Library of Medicine's database of drug labels.

Product	Storage on the label
Tretinoin cream (generic)	"Store below 80°F."
Tretinoin gel (generic)	"store below 30°C (86°F)."
Retin-A cream and gel	Gel "below 86°F", cream "below 80°F"
Retin-A Micro gel	"Store at 20° to 25°C (68° to 77°F)", with short periods from 59° to 86°F allowed. "Store pump upright."
Renova cream 0.02 percent	"Store at 25°C (77°F)", with short periods from 59° to 86°F allowed
Altreno lotion	"Store ALTRENO at room temperature between 68° to 77°F (20° to 25°C)." Also: "Protect from freezing."
Atralin gel	68° to 77°F, and kept from freezing
Ziana gel (clindamycin and tretinoin)	"Store ZIANA Gel at room temperature, 59° to 86°F (15° to 30°C). Do not freeze." Also: "Protect from light."
Tri-Luma cream (tretinoin with hydroquinone and a steroid)	"Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing."

MedlinePlus, the library's patient site, gives one general rule for tretinoin: "Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not allow the medication to freeze."

The limit differs between the cream and the gel, and the guide to tretinoin cream vs gel explains the forms.

Should tretinoin go in the fridge?

Most labels in the table give a range around room temperature, which the Altreno leaflet puts at 68° to 77°F. Only one product in the table is kept cold: Tri-Luma cream, which combines tretinoin with hydroquinone and a steroid and is prescribed for melasma, a condition that causes dark patches on the face. The hydroquinone and tretinoin guide covers that cream.

For the others, compare the numbers. The Tri-Luma label puts a refrigerator at 36° to 46°F. The Retin-A Micro, Altreno and Atralin labels ask for 68° to 77°F, and the Ziana label sets a lower limit of 59°F. A refrigerator is colder than each of those ranges. The generic cream label says only "Store below 80°F" and sets no lower limit, while MedlinePlus says room temperature.

Several sources name freezing directly. The Altreno, Atralin and Ziana labels and MedlinePlus each say to keep the product from freezing. If you want to keep your tube in the fridge, ask your pharmacist whether your product allows it.

Heat, moisture and the bathroom

Two sources advise against keeping medicines in the bathroom. MedlinePlus says "not in the bathroom". The FDA says storage in a place "such as a damp bathroom cabinet ... can contribute to decreased effectiveness in medicines that have not reached their posted expiration date."

The FDA suggests "a cool, dry place such as a dresser drawer, storage box, closet shelf, or kitchen cabinet." A bedroom drawer also suits a product that is used at bedtime, as how to use tretinoin explains.

The generic leaflet names a top temperature, 120°F (49°C), next to its line about heat. Keep the tube out of places that get hot, such as a spot in direct sun.

One form adds a fire rule. The standard tretinoin gel is 90 percent alcohol by weight, and its label says: "GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE."

What light does to tretinoin

The Tri-Luma label says of tretinoin: "It is highly reactive to light and moisture." The Ziana label says: "Protect from light." Four laboratory studies measured the effect.

Study	What was exposed to light	Result
Cutis, 2002	Tretinoin gel 0.025 percent, 24 hours of fluorescent light	Up to 69 percent of the tretinoin broke down
Cutis, 2002	Microsphere gel 0.1 percent, the same light	98 percent of the tretinoin remained unchanged
Cutis, 2006	Tretinoin gel 0.025 percent, 2 and 6 hours of simulated sunlight	19 and 10 percent remained unchanged
Cutis, 2006	Microsphere gel 0.1 percent, the same light	94 and 84 percent remained stable
British Journal of Dermatology, 1998	Tretinoin gel 0.025 percent mixed with a 10 percent benzoyl peroxide lotion, in light	95 percent of the tretinoin broke down in 24 hours
International Journal of Pharmaceutics, 2008	Tretinoin under light made to copy sunlight	UVA, one type of ultraviolet light, caused most of the breakdown

Read these results with their limits. The two Cutis studies were written at Johnson & Johnson consumer products companies, and the 1998 study at Galderma R&D, the research unit of a drug company. All four are laboratory tests of product exposed to light. No source read for this hub measured a closed tube kept in a drawer.

The practical points come from the labels: keep the cap closed, and keep the product away from heat and light. The benzoyl peroxide result is covered in retinoid with benzoyl peroxide.

How to throw away an expired tube

MedlinePlus says of tretinoin: "Do not flush this medication down the toilet. Use a medicine take-back program." The FDA agrees for all medicines: "A drug take-back location, or pre-paid drug mail-back envelope, are the preferred ways to dispose of expired, unwanted, or unused medicine."

Do not hand an old tube to someone else. The tretinoin leaflet says: "Do not allow anyone else to use this medication." The Retin-A Micro leaflet adds a reason: "It may harm them."

Other dates to check

Tretinoin bought online. The FDA warns that unsafe online pharmacies exist and that "the products they provide may be fake, expired or otherwise unsafe." Check the date on every delivery. The guide on how to get tretinoin lists the FDA's signs of a safe pharmacy.

Your sunscreen. The tretinoin labels ask for sunscreen, and sunscreen has a date too. The FDA says "a sunscreen product that doesn't have an expiration date should be considered expired three years after purchase." See does sunscreen expire and sunscreen with tretinoin.

When to ask your pharmacist or prescriber

• The date has passed. Ask for a new prescription or a refill, and take the old tube to a take-back program.
• The tube froze or sat in heat above the limit on its label. Ask your pharmacist whether to replace it.
• Your acne is no better after 12 weeks on a tube that is in date. NICE, the guideline body in England, says to review acne treatment at 12 weeks. See your prescriber.
• Your skin reacts badly. The leaflet says: "If you are experiencing severe or persistent irritation, discontinue the use of tretinoin and consult your physician." Deep, painful lumps or new scars also need a doctor or a dermatologist in person.