Label: CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT- benzoyl peroxide cream
- NDC Code(s): 63824-438-01
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
- 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 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.
- 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
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- 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. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-438 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BENTONITE (UNII: A3N5ZCN45C) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-438-01 1 in 1 CARTON 12/06/2017 1 28 g 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 Drug M006 12/06/2017 Labeler - RB Health (US) LLC (081049410)
