Label: SLMD SPOT TREATMENT- benzoyl peroxide gel
- NDC Code(s): 59958-401-01
- 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
-
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)
Propanediol
Glycerin
Neopentyl Glycol Diethylhexanoate
Dimethicone
Cyclopentasiloxane
Cyclohexasiloxane
Titanium Dioxide
C12-15 Alkyl Benzoate
Stearic Acid
Behenoxy Dimethicone
Behenyl Alcohol
Glyceryl Stearate
PEG-100 Stearate
Myristoyl Tetrapeptide-13
Acetyl Carboxymethyl Cocoyl Glycine
Panthenol
Tocopheryl Acetate
Sodium Hyaluronate
Allatoin
Glyceryl Oleate
Behenic Acid
Steareth-21
Steareth-2
Silica
Carbomer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Phenoxyethanol
Ethylhexylglycerin
Fragrance
Tromethamine
Alumina
Polyhydroxystearic Acid - Do not use if
- Stop us and ask a doctor if
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLMD SPOT TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59958-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 51.9 g in 100 g PROPANEDIOL (UNII: 5965N8W85T) 5 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 3 g in 100 g NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) 3 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59958-401-01 1 in 1 PACKAGE 03/24/2017 1 15 g 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 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(59958-401)
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