Label: PREP EVERYDAY CLEAR ACNE- salicylic acid acne treatment solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70231-0017-1 - Packager: PREP Cosmetics 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 October 17, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
- Clean the skin thoroughy before applying the product.
- 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.
- Sensitivity Test for a New User
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INACTIVE INGREDIENT
Azelaic Acid, Butylene Glycol, Chamaemelum Nobile Flower Oil, Ethylhexylglycerin, Geranium Maculatum Root Oil, Hydroxyethyl Cellulose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Distarch Phosphate, High Amylose Corn, Lavender Oil, Mandelic Acid, PEG-12 Glyceryl Dimyristate, PEG-23 Glyceryl Distearate, Phytate Sodium, Polysorbate 60, Potassium Sorbate, Propanediol, Rosa Canina Fruit, Salix Nigra Bark, Sorbitol, Squalane, Water
- Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREP EVERYDAY CLEAR ACNE
salicylic acid acne treatment solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70231-0017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) PHYTATE SODIUM (UNII: 88496G1ERL) GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX) POLYSORBATE 60 (UNII: CAL22UVI4M) LAVENDER OIL (UNII: ZBP1YXW0H8) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X) SALIX NIGRA BARK (UNII: QU52J3A5B3) HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) PEG-23 GLYCERYL DISTEARATE (UNII: 527412VE0U) SORBITOL (UNII: 506T60A25R) HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45) MANDELIC ACID (UNII: NH496X0UJX) AZELAIC ACID (UNII: F2VW3D43YT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70231-0017-1 1 in 1 CARTON 11/06/2015 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/06/2015 Labeler - PREP Cosmetics LLC (053793815) Registrant - Richard Hamer Associates LLC (067731889) Establishment Name Address ID/FEI Business Operations Taka USA, Inc dba Cosmetic Innovations 802860515 manufacture(70231-0017) , pack(70231-0017)
