Label: PURIPATCH FOR ACNE TREATMENT- salicylic acid patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71727-106-01, 71727-106-02 - Packager: iMode Korea, 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 August 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
- Keep out of reach of children
- Directions
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Inactive ingredients
Water, Methylpropanediol, Glycerin, Hydrolyzed Egg Shell Membrane, Pearl Extract, Ethylhexylglycerin, Xylitylglucoside, Anhydroxylitol, xylitol, Glucose, Sodium Pca, Sodium Lactate, Hydroxyethyl Urea, Aspartic Acid, PCA, Glycine, Alanine, Serine, Valine, Dipotassium Glycyrrhizate, Proline, Threonine, Isoleucine, Histidine, Phenylalanine, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCl, Maltodextrin, Sodium Starch Octenylsuccinate, Sodium Hyaluronate, Butylene Glycol, Hydrolyzed Jojoba Esters, Betaine, Carbomer, Ammonium Acryloyldimethyltaurate/Vp Copolymer, t-Butyl Alcohol, PEG-60 Hydrogenated Castor Oil, Hexyl Laurate, Caffeine, Sodium Acrylates Copolymer, Lecithin, PEG-2M, Silica, Arginine, Caprylic/Capric Triglyceride, Cellulose Gum, Hydroxyacetophenone, Hexylene Glycol, Caprylhydroxamic Acid, Propanediol, Ethyl Hexanediol, 1,2-Hexanediol, Chlorphenesin, Dehydroacetic Acid, Disodium EDTA, Fragrance
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INGREDIENTS AND APPEARANCE
PURIPATCH FOR ACNE TREATMENT
salicylic acid patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71727-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.6 g in 100 mm Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) KAOLIN (UNII: 24H4NWX5CO) LIMONENE, (+)- (UNII: GFD7C86Q1W) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) SODIUM HYDROXIDE (UNII: 55X04QC32I) LINALOOL, (-)- (UNII: 3U21E3V8I2) WATER (UNII: 059QF0KO0R) ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) NONOXYNOL-30 (UNII: JJX07DG188) POLYSORBATE 80 (UNII: 6OZP39ZG8H) VITIS VINIFERA SEED (UNII: C34U15ICXA) LAURETH-7 (UNII: Z95S6G8201) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71727-106-02 72 in 1 BOX 08/13/2020 1 NDC:71727-106-01 12.25 mm in 1 PATCH; 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 08/13/2020 Labeler - iMode Korea, Inc. (694627846) Registrant - iMode Korea, Inc. (694627846) Establishment Name Address ID/FEI Business Operations Kovas Co., Ltd. 688783559 manufacture(71727-106)