CLEANSING FOAMING GEL ACNE PRO SKIN- zinc pidolate gel

Cleansing Foaming Gel by

Drug Labeling and Warnings

Cleansing Foaming Gel by is a Otc medication manufactured, distributed, or labeled by LANGE SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

The Answer to Acne Prone Skin
Cleansing Foaming Gel Lange

• Purifying with an astingent activity,
• Anti-inflammatory,
• Antiseptic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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

Warnings

DOSAGE & ADMINISTRATION

120 mL / 4.05 FL OZ.

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

INGREDIENTS AND APPEARANCE

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

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)