Label: CLEARASIL STUBBORN ACNE CONTROL 5IN1 DAILY PADS- salicylic acid cloth
- NDC Code(s): 63824-439-90
- Packager: RB Health (US) 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.
Drug Label Information
Updated September 14, 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
- Use
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Warnings
For external use only
When using this product
- avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
- 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.
- limit use to face and neck
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Directions
- clean the skin thoroughly before applying this product
- wipe a pad over face and neck to 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
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 90 Pad Jar Label
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INGREDIENTS AND APPEARANCE
CLEARASIL STUBBORN ACNE CONTROL 5IN1 DAILY PADS
salicylic acid clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.03 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ISOCETETH-20 (UNII: O020065R7Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM HYDROXIDE (UNII: 55X04QC32I) TROLAMINE (UNII: 9O3K93S3TK) ALLANTOIN (UNII: 344S277G0Z) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-439-90 90 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/05/2017 Labeler - RB Health (US) LLC (081049410) Establishment Name Address ID/FEI Business Operations Kleen Test Products Corporation 168165814 manufacture(63824-439)
