Label: CLEANSING FOAMING GEL ACNE PRO SKIN- zinc pidolate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51830-053-06 - Packager: LANGE SAS
- 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 July 18, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Ingredients:AQUA,SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-40 HYDROGENATED CASTOR OIL DECYL GLUCOSIDE, ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER, IRIS FLORENTINA ROOT EXTRACT, ZINC PCA, ZINC ACETYLMETHIONATE, HELIANTHUS ANNUUS SEED EXTRACT, HEDERA HELIX LEAF/STEM EXTRACT,SALICYLIC ACID, GLYCERIN,PEG-8, CAPRYLYL GLYCOL,PPG-1-PEG-9 LAURYL GLYCOL ETHER,SODIUM POLYACRYLATE,SODIUM CHLORIDE,ALCOHOL,PROPYLENE GLYCOL,BUTYLENE GLYCOL,PHYTIC ACID,BIOTIN,TRIETHANOLAMINE,PARFUM,LINALOOL,ALPHA-ISOMETHYL IONONE, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE,RETINYL PALMITATE,BHT,METHYLISOTHIAZOLINONE,CHLORHEXIDINE DIGLUCONATE,PHENOXYETHANOL,METHYLPARABEN,BUTYLPARABEN, ETHYLPARABEN,PROPYLPARABEN,ISOBUTYLPARABEN,CI 42090 (BLUE 1)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEANSING FOAMING GEL ACNE PRO SKIN
zinc pidolate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC PIDOLATE (UNII: C32PQ86DH4) (ZINC PIDOLATE - UNII:C32PQ86DH4) ZINC PIDOLATE .072 mg in 120 mg SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 12 mg in 120 mg IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) (IRIS GERMANICA VAR. FLORENTINA ROOT - UNII:M30XO5X4XD) IRIS GERMANICA VAR. FLORENTINA ROOT 1.8 mg in 120 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ZINC ACETYLMETHIONATE (UNII: Q98AWH82LP) SUNFLOWER SEED (UNII: R9N3379M4Z) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) FYTIC ACID (UNII: 7IGF0S7R8I) BIOTIN (UNII: 6SO6U10H04) TROLAMINE (UNII: 9O3K93S3TK) LINALOOL, (+/-)- (UNII: D81QY6I88E) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Product Characteristics Color blue (FD&C BLUE NO. 1) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51830-053-06 120 mg in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 07/18/2012 Labeler - LANGE SAS (275956105) Registrant - LANGE SAS (275956105) Establishment Name Address ID/FEI Business Operations LANGE SAS 275956105 manufacture(51830-053)
