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

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/12

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  • ACTIVE INGREDIENT

    Key Active Ingredients
    Zinc PCA, Salicylic Acid, Iris Flower Extract Close
  • PURPOSE

    The Answer to Acne Prone Skin
    Cleansing Foaming Gel Lange
    • Purifying with an astingent activity,
    • Anti-inflammatory,
    • Antiseptic
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Close
  • 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. Close
  • WARNINGS

    Warnings
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  • DOSAGE & ADMINISTRATION

    120 mL / 4.05 FL OZ.
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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) Close
  • INGREDIENTS AND APPEARANCE
    CLEANSING FOAMING GEL  ACNE PRO SKIN
    zinc pidolate gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51830-053
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC PIDOLATE (ZINC PIDOLATE) ZINC PIDOLATE .072 mg  in 120 mg
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 12 mg  in 120 mg
    IRIS GERMANICA VAR. FLORENTINA ROOT (IRIS GERMANICA VAR. FLORENTINA ROOT) IRIS GERMANICA VAR. FLORENTINA ROOT 1.8 mg  in 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    COCAMIDOPROPYL BETAINE  
    DECYL GLUCOSIDE  
    ZINC ACETYLMETHIONATE  
    SUNFLOWER SEED  
    HEDERA HELIX LEAF  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    CAPRYLYL GLYCOL  
    SODIUM POLYACRYLATE (8000 MW)  
    SODIUM CHLORIDE  
    ALCOHOL  
    PROPYLENE GLYCOL  
    BUTYLENE GLYCOL  
    FYTIC ACID  
    BIOTIN  
    TROLAMINE  
    LINALOOL, (+/-)-  
    ISOMETHYL-.ALPHA.-IONONE  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE  
    BUTYLATED HYDROXYTOLUENE  
    METHYLISOTHIAZOLINONE  
    CHLORHEXIDINE GLUCONATE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    BUTYLPARABEN  
    ETHYLPARABEN  
    PROPYLPARABEN  
    ISOBUTYLPARABEN  
    VITAMIN A PALMITATE  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    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)
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