Label: CA22 BENZOYL PEROXIDE CLEANSING- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 82575-122-04, 82575-122-08, 82575-122-15 - Packager: Curology 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 December 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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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 the product less frequently or in a lower concentration.
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Directions
Dampen skin and massage a thin layer onto the entire affected area and rinse thoroughly one to two times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other Information
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 80 ml Tube Box
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INGREDIENTS AND APPEARANCE
CA22 BENZOYL PEROXIDE CLEANSING
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82575-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Disodium Cocoamphodiacetate (UNII: 18L9G3U51M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Hydroxide (UNII: 55X04QC32I) Phenoxyethanol (UNII: HIE492ZZ3T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Allantoin (UNII: 344S277G0Z) Panthenol (UNII: WV9CM0O67Z) Ethylhexylglycerin (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82575-122-04 1 in 1 BOX 12/01/2022 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:82575-122-08 1 in 1 BOX 12/01/2022 2 80 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:82575-122-15 1 in 1 BOX 12/01/2022 3 150 mL 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 12/01/2022 Labeler - Curology Inc. (104103284) Registrant - Pharmco Laboratories, Inc. (096270814) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories, Inc. 096270814 MANUFACTURE(82575-122) , LABEL(82575-122) , PACK(82575-122) , ANALYSIS(82575-122)
