Label: NUVILEO SKIN PERFECTING ACNE- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-500-02 - Packager: Cosmetic Specialty Labs, 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 15, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Allantoin, Aloe Barbadensis Leaf, Aloe barbadensis mill, C13-14 Isoparaffin, Caprylyl Glycol, Citrus Grandis (Grapefruit) Peel Oil, Cyclomethicone, Disodium EDTA, Emulsifying Wax, Ethylhexyl Stearate, Hydrastis canadensis L., Laureth-7, Olea Europaea (Olive) Fruit Oil, Panax quinquefolius L., Passiflora Incarnata, Phenoxyethanol, Polyacrylamide, Purified Water, Sorbitol, Tocopheryl Acetate, Triethanolamine
- PRINCIPAL DISPLAY PANEL - 60 ml Tube Label
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INGREDIENTS AND APPEARANCE
NUVILEO SKIN PERFECTING ACNE
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-500 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 Allantoin (UNII: 344S277G0Z) Aloe Vera Leaf (UNII: ZY81Z83H0X) Aloe Vera Whole (UNII: KIZ4X2EHYX) C13-14 Isoparaffin (UNII: E4F12ROE70) Caprylyl Glycol (UNII: 00YIU5438U) Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44) Cyclomethicone (UNII: NMQ347994Z) Edetate Disodium (UNII: 7FLD91C86K) Ethylhexyl Stearate (UNII: EG3PA2K3K5) Hydrastis Canadensis Whole (UNII: R763EBH88T) Laureth-7 (UNII: Z95S6G8201) Olive Oil (UNII: 6UYK2W1W1E) Panax Quinquefolius Whole (UNII: 0P067WOA1X) Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) Phenoxyethanol (UNII: HIE492ZZ3T) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-500-02 60 mL in 1 TUBE; 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 06/30/2015 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs 032973000 MANUFACTURE(58133-500)