Label: ACNE MEDICATION 10- benzoyl peroxide gel
- NDC Code(s): 0536-4092-56
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Benzoyl Peroxide 10%Close
- treats acne
- dries up acne pimples
- helps prevent new acne pimples
For external use only
When using this product
- apply to affected ares only
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- this product may bleach hair or dyed fabrics
- with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
- skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately.
- clean the skin thoroughly before applying
- cover the entire affected area with a thin layer 1 to 3 times daily
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
- if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
- Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
- Other information
- store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
- Lot number & expiration date: See box or crimp of the tube
- Inactive ingredients
Brij 30, carbomer, diisopropanolamine, edetate sodium, Purified waterClose
- Principal display panel
10% Benzoyl Peroxide Gel
- INGREDIENTS AND APPEARANCE
ACNE MEDICATION 10
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-4092 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER STEARETH-30 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) DIISOPROPANOLAMINE EDETATE DISODIUM Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-4092-56 1 in 1 CARTON 1 42.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 10/29/2012 Labeler - Rugby Laboratories (191427277)