Label: TRULYCLEAR THE ONE-STEP ACNE SOLUTION- salicylic acid soap
- NDC Code(s): 71527-3492-3
- Packager: RK RESPONSE 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 July 11, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Use as your only cleanser and apply to face, back or chest in the morning and evening with warm water. Leave on skin for 3-5 minutes, then wash off thoroughly with water. If excessive dryness or peeling occurs, reduce usage from 2 to 1 time daily and only leave on skin for 2 minutes. KEEP BAR DRY WHEN NOT IN USE.
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INACTIVE INGREDIENT
Iactive Ingredients: Sodium Palmate, Sodium Cocoate, Water (Aqua), Palmitic Acid, Mentha Piperita (Peppermint) Oil, Sodium Hyaluronate, Glycerin, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Collagen, Tetrasodium EDTA, Tetrasodium Etidronate, Retinyl Palmitate, Tocopheryl Acetate, Sericin, Aloe Barbadensis Leaf Juice, Maltodextrin, Citric Acid, Potassium Sorbate, Euterpe Oleracea Fruit Extract, Lycium Barbarum Fruit Extract
- Label
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INGREDIENTS AND APPEARANCE
TRULYCLEAR THE ONE-STEP ACNE SOLUTION
salicylic acid soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71527-3492 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) SODIUM PALMATE (UNII: S0A6004K3Z) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALOE (UNII: V5VD430YW9) SHEA BUTTER (UNII: K49155WL9Y) SUNFLOWER OIL (UNII: 3W1JG795YI) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) PEPPERMINT OIL (UNII: AV092KU4JH) PALMITIC ACID (UNII: 2V16EO95H1) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SILK SERICIN (UNII: 0N1VMU8G9W) SODIUM COCOATE (UNII: R1TQH25F4I) EDETATE SODIUM (UNII: MP1J8420LU) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71527-3492-3 99 g in 1 BOX; Type 0: Not a Combination Product 06/26/2017 01/31/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/26/2017 01/31/2026 Labeler - RK RESPONSE INC. (079866826)
