Label: SLMD AM BENZOYL PEROXIDE ACNE TREATMENT- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59958-402-01 - Packager: Owen Biosciences, Inc.
- 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 January 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Use
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Warnings
For external use only
When using this product
skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the 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 this product less frequently or in a lower concentration
- Keep out of reach of children.
- Directions
- PURPOSE
- DOSAGE & ADMINISTRATION
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Inactive ingredients
Water (Aqua)
Behenoxy Dimethicone
Cyclohexasiloxane
Cyclopentasiloxane
Dimethicone
Glyceryl Stearate SE
Acetyl Carboxymethyl Cocoyl-Glycine
Lysozyme
Phenoxyethanol
Tocopheryl Acetate
Decylene Glycol
Maltodextrin
Glyceryl Stearate
PEG-100 Stearate
Caprylyl Glycol
C13-14 Isoparaffin
Laureth-7
Polyacrylamide
Sodium Carboxymethyl Betaglucan
Cocoglycerides
Glycerin
Lecithin
Palmitoyl Myristyl Serinate
Syringa Vulgaris (Lilac) Extract
Butylene Glycol
Propanediol
Mirabilis Jalapa Extract
Aloe Barbadensis Leaf Juice
Capryloyl Glycine
Polyglyceryl-10 Laurate
Tromethamine
Beta-Glucan
Myristoyl Tetrapeptide-13
Acrylates/C10-30 Alkyl Acrylate Crosspolymer - Do not use if
- Stop us and ask a doctor if
- Acne Lotion Back.jpg
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INGREDIENTS AND APPEARANCE
SLMD AM BENZOYL PEROXIDE ACNE TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59958-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 70.14 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) 3.8 g in 100 g GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59958-402-01 1 in 1 PACKAGE 03/24/2017 1 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/22/2017 Labeler - Owen Biosciences, Inc. (790003045) Registrant - Owen Biosciences, Inc. (790003045) Establishment Name Address ID/FEI Business Operations Owen Biosciences, Inc. 790003045 manufacture(59958-402)
