TRETINOIN .1 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Tretinoin is used to treat acne. Tretinoin is also used to reduce fine wrinkles. Tretinoin is in a class of medications called retinoids. It works by increasing production of new skin cells and unclogging pores.
Read the full MedlinePlus article ↗- Honestly, it won't erase wrinkles — and the label is pretty direct about that. What it's approved to do is help reduce the appearance of fine wrinkles as part of a full routine tha...
- Will tretinoin actually get rid of my wrinkles?
- Redness, peeling, and irritation in the first couple of weeks are very common and usually mean your skin is adjusting — not that something is wrong. If it's tolerable, try hanging...
- My skin is really red and peeling after the first week — should I stop?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tretinoin — tap one for details:
Tretinoin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.308 | $103.84 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $2.21 | $99.41 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $2.71 | $121.88 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tretinoin .1 mg/gthis 00574-2301-45 | Padagis | 1 tube | $2.308 | AB | Availability likely | — |
| Tretinoin .1 mg/g 00378-8085-15 | Mylan | 1 tube | $3.115 | AB | Availability likely | +35% |
| Tretinoin .1 mg/g 21922-0056-04 | Encube | 1 tube | $3.115 | AB | Availability likely | +35% |
| Tretinoin .1 mg/g 59651-0712-14 | Aurobindo | 1 tube | $3.115 | AB | Availability likely | +35% |
| Retin-A .1 mg/g 00187-5172-15 | Bausch | 1 tube | — | AB | FDA listed | — |
| Tretinoin .1 mg/g 71335-2952-01 | Bryant | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00574-2301-15 | 1 TUBE in 1 CARTON (0574-2301-15) / 15 g in 1 TUBE | $3.11 / g | $46.72 | 2017-07-28 | Active |
| 00574-2301-45 You're viewing this | 1 TUBE in 1 CARTON (0574-2301-45) / 45 g in 1 TUBE | $2.31 / g | $103.84 | 2017-03-30 | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($2.31 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 52% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00574-2301-45?
What NDC number is used to bill for this package of TRETINOIN .1 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Indications and Usage: Tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
⏱️ Dosage and Administration ▾
Dosage and Administration: Tretinoin gel or cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application by the patient. Application may cause a transitory feeling of warmth or slight stinging.
In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur.
This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin preparations may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied ( see Precautions ).
⛔ Contraindications ▾
Contraindications: Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
⚠️ Warnings ▾
Warnings: GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C).
🤒 Adverse Reactions ▾
Adverse Reactions: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered.
Temporary hyper- or hypopigmentation has been reported with repeated application of a tretinoin preparation. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy ( see Dosage and Administration Section ).
🔄 Drug Interactions ▾
Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tretinoin is begun.
🤰 Pregnancy ▾
Pregnancy: Teratogenic effects. Pregnancy Category C. Oral tretinoin has been shown to be teratogenic in rats, mice, hamsters, and subhuman primates.
It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than the other species examined, fetal malformations were reported at doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose adjusted for total body surface area), although increased skeletal variations were observed at all doses.
A dose-related increase in embryolethality and abortion was reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in animal teratogenicity tests has generated equivocal results.
There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. There are other reports in New Zealand White rabbits administered doses of greater than 0.2 mg/kg/day (3.3 times the maximum human systemic dose adjusted for total body surface area) of an increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species.
In contrast, several well-controlled animal studies have shown that dermally applied tretinoin may be fetotoxic, but not overly teratogenic in rats and rabbits at doses of 1.0 and 0.5 mg/kg/day, respectively (8 times the maximum human systemic dose adjusted for total body surface area in both species). With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin.
Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area).
Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (20 times the maximum human systemic dose adjusted for total body surface area). There are no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use: Safety and effectiveness in a geriatric population have not been established. Clinical studies of tretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
🆘 Overdosage ▾
Overdosage: If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
🧬 Clinical Pharmacology ▾
Clinical Pharmacology: Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
📦 How Supplied / Storage and Handling ▾
How Supplied: Tretinoin Gel, USP NDC CODE Strength Qty. 0574-2325-15 0.025% 15 g 0574-2325-45 0.025% 45 g 0574-2301-15 0.01% 15 g 0574-2301-45 0.01% 45 g Tretinoin Cream, USP NDC CODE Strength Qty. 0574-2201-20 0.1% 20 g 0574-2201-45 0.1% 45 g 0574-2205-20 0.05% 20 g 0574-2205-45 0.05% 45 g 0574-2225-20 0.025% 20 g 0574-2225-45 0.025% 45 g
📦 Storage and Handling ▾
Storage Conditions: Tretinoin Gel, USP: store below 30°C (86°F). Tretinoin Cream, USP: store below 27°C (80°F)
📋 Description ▾
Description: Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Each gram of tretinoin gel contains tretinoin in either of two strengths, 0.025% (0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene, and alcohol 90% w/w. Each gram of tretinoin cream contains tretinoin in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a hydrophilic cream vehicle of: stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water.
Chemically, tretinoin is all-trans -retinoic acid. It has a molecular weight of 300.44 and has the following structural formula: chemical-structure-tretinoin.jpg
💬 Information for Patients ▾
PATIENT INSTRUCTIONS Acne Treatment IMPORTANT Read Directions Carefully Before Using THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR’S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED.
IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR. WARNINGS TRETINOIN GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE.
Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C).
PRECAUTIONS The effects of the sun on your skin. As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn. Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer.
The chances of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with tretinoin may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized. Laboratory findings.
When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient tretinoin. In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced.
There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing. Use caution in the sun.
When outside, even on hazy days, areas treated with tretinoin should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). For extended sun exposure, protective clothing, like a hat, should be worn.
Do not use artificial sunlamps while you are using tretinoin. If you do become sunburned, stop your therapy with tretinoin until your skin has recovered. Avoid excessive exposure to wind or cold.
Extremes of climate tend to dry or burn normal skin. Skin treated with tretinoin may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.
Possible problems. The skin of certain sensitive individuals may become excessively red, swollen, blistered or crusted. If you are experiencing severe or persistent irritation, discontinue the use of tretinoin and consult your physician.
There have been reports that, in some patients, areas treated with tretinoin developed a temporary increase or decrease in the amount of skin pigment (color) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to tretinoin or therapy was discontinued. Use other medication only on your doctor’s advice.
Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician’s instructions carefully. In addition, you should avoid preparations that may dry or irritate your skin.
These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos and hair permanent solutions. Do not allow anyone else to use this medication. Do not use other medications with tretinoin which are not recommended by your doctor.
The medications you have used in the past might cause unnecessary redness or peeling. If you are pregnant, think you are pregnant or are nursing an infant: No studies ha…