CLEANSING FOAMING GEL ACNE PRO SKIN- zinc pidolate, salicylic acid and iris germanica var. florentina root gel 
LANGE SAS

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.

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Key Active Ingredients
Zinc PCA, Salicylic Acid, Iris Flower Extract

The Answer to Acne Prone Skin
Cleansing Foaming Gel Lange

Keep out of reach of children.

Lange Gel will turn into foam, during application. It will cleanse skin thoroughly without any dryness effect, in order to avoid hyperseboohea phenomenon, a main cause of acne.

Warnings

120 mL / 4.05 FL OZ.

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)

box label

CLEANSING FOAMING GEL  ACNE PRO SKIN
zinc pidolate gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-053
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 7/2012
Document Id: 0867bfc3-a975-46d2-bd24-6fd33536b9fe
Set id: cab1d71c-e017-4ff3-853b-b0e47dc1ee79
Version: 3
Effective Time: 20120718
 
LANGE SAS