Label: ACNE DEEP PORE CLEANSING WASH- salicylic acid gel
- NDC Code(s): 54108-3700-1
- Packager: derma e
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
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Directions
- Moisten face and apply by massaging face gently, avoiding the delicate eye area.
- Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. Pat dry.
- 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.
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Inactive ingredients
Purified Water, Disodium Laureth Sulfosuccinate, Cocamidopropyl Hydroxysultaine (Coconut Derived), Cocamidopropylamine Oxide, PEG-150 Distearate, Polysorbate 20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin (Vegetable Derived), Lavandula Angustifolia (Lavender) Oil, Aniba Rosodora (Rosewood) Wood Oil, Salix Alba (Willow) Bark Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Decyl Glucoside (Plant Derived), Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.
- 1
- Certified Organic Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label
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INGREDIENTS AND APPEARANCE
ACNE DEEP PORE CLEANSING WASH
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54108-3700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) POLYSORBATE 20 (UNII: 7T1F30V5YH) TEA TREE OIL (UNII: VIF565UC2G) GLYCERIN (UNII: PDC6A3C0OX) LAVENDER OIL (UNII: ZBP1YXW0H8) ROSEWOOD OIL (UNII: F2522O5L7B) SALIX ALBA BARK (UNII: 205MXS71H7) MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54108-3700-1 175 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M006 01/01/2015 Labeler - derma e (148940450) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(54108-3700) Establishment Name Address ID/FEI Business Operations Topix Pharmaceuticals, Inc. 117745066 PACK(54108-3700)
