Label: BPO 6%- benzoyl peroxide cloth
- NDC Code(s): 42192-161-60
- Packager: Acella Pharmaceuticals, LLC
- 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 June 4, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
For external use only
When using this product
- avoid unnecessary sun exposure and use sunscreen
- keep away from eyes, lips and mouth
- avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild 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.
- wash the affected area once or twice daily
- wet face with water
- wet cloth with a little water and work into a full lather
- cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes.
- rinse thoroughly and pat dry
- discard cloth, do not flush
- If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often
- If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
- Other Information
cetostearyl alcohol, cocamidopropyl betaine, corn starch, deionized water, dimethyl isosorbide, glycerine, glycolic acid, hydrogenated castor oil, imidurea, methylparaben, mineral oil, PEG-14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate, sodium PCA and titanium dioxide.
Acella Pharmaceuticals, LLC
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
benzoyl peroxide cloth
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42192-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 60 mg Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) GLYCERIN (UNII: PDC6A3C0OX) GLYCOLIC ACID (UNII: 0WT12SX38S) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-161-60 60 in 1 CARTON 06/01/2018 1 1 in 1 PACKET; 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 06/01/2018 Labeler - Acella Pharmaceuticals, LLC (825380939) Establishment Name Address ID/FEI Business Operations Acella Pharmaceuticals, LLC 825380939 MANUFACTURE(42192-161)