Label: MICRONIZED BPO WASH- benzoyl peroxide gel
Contains inactivated NDC Code(s)
NDC Code(s): 58400-004-01, 58400-004-02
- Packager: Pharmco Laboratories 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 February 9, 2015
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- INDICATIONS & USAGE
- 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 the product less frequently or in a lower concentration.
- If going outside, apply sunscreen after using this product.
- Keep out of reach of children
- If swallowed get medical help or call a poison control center immediately.
Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and consult a physician or skin care professional.
- Other Ingredients
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.9 kg Bottle Label
INGREDIENTS AND APPEARANCE
MICRONIZED BPO WASH
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-004 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 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Disodium Cocoamphodiacetate (UNII: 18L9G3U51M) Allantoin (UNII: 344S277G0Z) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Panthenol (UNII: WV9CM0O67Z) Hyaluronate Sodium (UNII: YSE9PPT4TH) Propylene Glycol (UNII: 6DC9Q167V3) Edetate Disodium (UNII: 7FLD91C86K) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58400-004-01 240 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 2 NDC:58400-004-02 3900 g in 1 BOTTLE, PLASTIC; 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 06/01/2012 Labeler - Pharmco Laboratories Inc. (096270814) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories Inc. 096270814 MANUFACTURE(58400-004) , LABEL(58400-004) , PACK(58400-004) , ANALYSIS(58400-004)