Label: ACNE SPOT TREATMENT- benzoyl peroxide cream
- NDC Code(s): 78518-013-01
- Packager: MONAT GLOBAL CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 3, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only
When using this product
- skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
- avoid unnecessary sun exposure and use sunscreen
- avoid contact with eyes, lips, and mouth.
- avoid contact with hair and dyed fabrics, which may be bleached by this product.
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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Directions
Directions
- Clean skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside. apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and sak a doctor.
Sensitivity Test for a 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.
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INACTIVE INGREDIENT
Inactive Ingredients
Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.
- Questions or Comments
- PRIMARY PACKAGE
- OUTER PACKAGE
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INGREDIENTS AND APPEARANCE
ACNE SPOT TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78518-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) PENTYLENE GLYCOL (UNII: 50C1307PZG) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2) HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2) FU LING (UNII: XH37TWY5O4) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78518-013-01 1 in 1 CARTON 04/04/2023 1 15 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 04/04/2023 Labeler - MONAT GLOBAL CORP (027036949) Establishment Name Address ID/FEI Business Operations Dermacare MFG 116817470 manufacture(78518-013)
