Important: This page is general information, not medical advice. It does not recommend or prescribe any treatment. Always consult your doctor or pharmacist before starting, stopping or changing any medicine.
Quick facts
- How it is given
- topical
- Type
- human prescription drug
- RxNorm ID
- 848176
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone dipropionate cream (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. ( 1 )
About this medicine
Betamethasone dipropionate cream USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains: 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate, propylene glycol, purified water, sodium hydroxide, sorbitol solution, white petrolatum and white wax. Chemical Structure
How it works
12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate cream (augmented) in corticosteroid responsive dermatoses is unknown.
Who should not take it
Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Hypersensitivity to any component of this medicine. ( 4 )
Warnings and cautions
Effects on endocrine system: Betamethasone dipropionate cream (augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Betamethasone dipropionate cream (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2 ) 5.1 Effects on Endocrine System Betamethasone dipropionate cream (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. Betamethasone dipropionate cream (augmented), 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis. The results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range. In an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of HPA axis suppression. Four (4) subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. […]
Reported side effects
The most common adverse reaction reported in 0.4% of adult patients is stinging. ( 6.1 ) The most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. ( 6.1 , 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials, involving 242 adult subjects, the adverse reaction associated with the use of betamethasone dipropionate cream (augmented) reported at a frequency of 0.4% was stinging. It occurred in 1 subject. In a controlled clinical trial involving 67 pediatric subjects from 3 months to 12 years of age, the adverse reactions associated with the use of betamethasone dipropionate cream (augmented) occurred in 7 of 67 (10%) subjects. Reported reactions included signs of skin atrophy (telangiectasia, bruising, shininess). 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, skin atrophy, striae, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.
Use in specific groups
8.1 Pregnancy Risk Summary There are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. 8.2 Lactation Risk Summary There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. […]
Storing it safely
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Before you take anything new
Tell your pharmacist or doctor about every medicine you take — including ones bought without a prescription, herbal products and supplements. Interactions are one of the most common avoidable causes of harm from medicines, and a pharmacist can check your full list in a couple of minutes.
This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 26 September 2025. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.