Label: SALICYLIC ACID ACNE TREATMENT- salicylic acid soap
- NDC Code(s): 74553-012-01
- Packager: Xtreme Tools International, 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 September 7, 2023
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- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warning
- When using this product
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients
Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut)
Oil, Leptospermum Scoparium Branch/Leaf (Manuka) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Calendula Officinalis
Flower Extract, Aloe Barbadensis Leaf Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance. - QUESTIONS
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
SALICYLIC ACID ACNE TREATMENT
salicylic acid soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74553-012 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 PALMATE (UNII: S0A6004K3Z) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) SODIUM COCOATE (UNII: R1TQH25F4I) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCONUT OIL (UNII: Q9L0O73W7L) MANUKA OIL (UNII: M6QU9ZUH2X) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74553-012-01 255 g in 1 BOX; Type 0: Not a Combination Product 09/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 09/11/2023 Labeler - Xtreme Tools International, Inc (125398904)