Label: DEFENSE ACNE CARE 2% SALICYLIC ACID- salicylic acid 2% soap
- NDC Code(s): 70856-3582-0
- Packager: Defense Soap 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 June 12, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEFENSE ACNE CARE 2% SALICYLIC ACID
salicylic acid 2% soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70856-3582 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM GLUCONATE (UNII: R6Q3791S76) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) OATMEAL (UNII: 8PI54V663Y) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) PALM ACID (UNII: B6G0Y5Z616) SODIUM PALMATE (UNII: S0A6004K3Z) SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O) PALM KERNEL ACID (UNII: 79P21R4317) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70856-3582-0 119 g in 1 CARTON; Type 0: Not a Combination Product 12/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 12/05/2019 Labeler - Defense Soap LLC (780587353)