Label: BENZOYL PEROXIDE liquid
- NDC Code(s): 67405-825-05, 67405-825-08
- Packager: Harris Pharmaceutical, 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.
Updated December 24, 2019
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
For external use only.
- Avoid contact with eyes, eyelids, lips and mucous membranes.
When using this product
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with eyes, lips, and mouth.
- Avoid contact with hair or 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.
- 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.
- Clean the skin thoroughly before applying this product.
- One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
- 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.
- Follow directions in the sunscreen labeling.
- If irritation or sensitivity develops stop use of both products and ask a doctor.
- Other information
Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 148 g Bottle Label
INGREDIENTS AND APPEARANCE
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67405-825 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength cetyl alcohol (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) edetate disodium (UNII: 7FLD91C86K) glycerin (UNII: PDC6A3C0OX) laureth-12 (UNII: OAH19558U1) magnesium aluminum silicate (UNII: 6M3P64V0NC) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium coco-sulfate (UNII: 3599J29ANH) sodium lauroamphoacetate (UNII: SLK428451L) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color WHITE (viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67405-825-05 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2011 2 NDC:67405-825-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/18/2011 Labeler - Harris Pharmaceutical, Inc. (617204370) Establishment Name Address ID/FEI Business Operations Groupe Parima Montreal 252437850 MANUFACTURE(67405-825)