Label: PURE NERIUM ACNE THERAPY- salicylic acid 2.0% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72216-227-13, 72216-227-32 - Packager: Nerium SkinCare, Inc.
- Category: HUMAN OTC DRUG LABEL
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 3, 2019
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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INSTRUCTIONS FOR USE
• Clean the skin thoroughly before applying this 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 to 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. Apply product sparingly to one or two small affected ares during the first 3 days. If no discomfort occurs, follow the directions stated above. - OTHER SAFETY INFORMATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice, Nerium Oleander Leaf Extract (NAE8®), Water (Aqua), Propanediol, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Cetyl Alcohol, Glycerin, Glyceryl Stearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Caprylic/Capric Triglyceride, Dimethicone, Ricinus Communis (Castor) Seed Oil, Glyceryl Caprylate, Sorbitan Olivate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Allantoin, Arginine, Avena Sativa Kernel Flour (Colloidal Oatmeal), Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens (Geranium) Flower Oil, Tocopherol, Fragrance, Leuconostoc/Radish Root Ferment Filtrate, Pullulan, Ocimum Basilicum (Basil) Extract, Linum Usitatissimum (Linseed) Seed Oil, Carum Petroselinum (Parsley) Extract, Benzyl Alcohol, Potassium Sorbate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Sea Salt, Mahonia Aquifolium (Oregon Grape) Root Extract, Sodium Benzoate, Muriella Aurantiaca/Ruttnera Lamellosa Oil (Plankton Extract), Citric Acid, Lecithin - QUESTIONS
- DOSAGE & ADMINISTRATION
- Principal Display Panel
- PURE NERIUM® -ACNE THERAPY CREAM, 30.3g/1.07 FL.OZ.
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INGREDIENTS AND APPEARANCE
PURE NERIUM ACNE THERAPY
salicylic acid 2.0% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72216-227 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 MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) PULLULAN (UNII: 8ZQ0AYU1TT) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) WATER (UNII: 059QF0KO0R) BETASIZOFIRAN (UNII: 2X51AD1X3T) XANTHAN GUM (UNII: TTV12P4NEE) OATMEAL (UNII: 8PI54V663Y) SHEA BUTTER (UNII: K49155WL9Y) TOCOPHEROL (UNII: R0ZB2556P8) EGG SHELL MEMBRANE (UNII: N7QBR4212V) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETEARYL OLIVATE (UNII: 58B69Q84JO) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BENZOATE (UNII: OJ245FE5EU) MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3) PROPANEDIOL (UNII: 5965N8W85T) LINSEED OIL (UNII: 84XB4DV00W) PARSLEY (UNII: 58FMD0Q0EV) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SEA SALT (UNII: 87GE52P74G) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN OLIVATE (UNII: MDL271E3GR) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) ALLANTOIN (UNII: 344S277G0Z) ARGININE (UNII: 94ZLA3W45F) OLIVE OIL (UNII: 6UYK2W1W1E) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72216-227-32 1 in 1 CARTON 09/16/2019 1 NDC:72216-227-13 30.3 g in 1 BOTTLE, PUMP; 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 02/28/2019 Labeler - Nerium SkinCare, Inc. (859420916) Registrant - Nerium SkinCare, Inc. (859420916)