Label: CT07 BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel
- NDC Code(s): 58400-024-02
- Packager: Pharmco Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 23, 2024
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
-
WARNINGS
- For external use only.
When using this product
- Skin irritation & 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 sunscreen.
- Avoid contact with 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 lower concentration.
- If going outside, apply sunscreen after using this product.
-
DIRECTIONS
- Clean the skin thoroughly before applying this product.
- Clover the entire affected area with a thin layer one to three times per day.
- Because excessive drying 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 and 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 both products and ask doctor.
- OTHER INGREDIENTS
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
-
INGREDIENTS AND APPEARANCE
CT07 BENZOYL PEROXIDE TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-024 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 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58400-024-02 60 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M006 07/01/2024 Labeler - Pharmco Laboratories, Inc. (096270814) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories Inc. 119071691 ANALYSIS(58400-024) , MANUFACTURE(58400-024) , PACK(58400-024) , LABEL(58400-024) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories Inc. 119071697 MANUFACTURE(58400-024) , PACK(58400-024) , LABEL(58400-024)
