Label: PREPARING TONIC- salicylic acid lotion 

  • 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 02/13

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  • ACTIVE INGREDIENT

    KEY ACTIVE INGREDIENTS
    Zinc PCA, Salicyclic Acid, Iris Flower Extract, Stinging Nettle

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  • PURPOSE

    PREPARING TONIC LOTION
    With Sebum-Regulator Zinc PCA,
    Anti-Microbial Salicylic Acid and Stinging Nettle Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • INDICATIONS & USAGE

    PREPARING TONIC LOTION LANGE
    LANGE Tonic Lotion will help to minimise pore size with its astringent ingredients and boost sebum regulation with its Zinc PCA extracts. Its Salicylic Acid limits bacterial growht and Stinging Nettle extract is antiseptic and Anti-Inflammatory. Skin is smoother and complexion is brighter with Tonic Lotion main actions:
    Clears away dead cells,
    Prevents blackheads formation,
    Absorbs the excess of sebum.

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  • WARNINGS

    Not to be used for children under three years of age. Avoid contact with Eyes.
    For external use only. If skin has allergic reaction, stop use immediately.

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  • DOSAGE & ADMINISTRATION

    180 ml
    6.08 FL. OZ

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  • INACTIVE INGREDIENT

    WATER
    PROPYLENE GLYCOL
    URTICA DIOICA EXTRACT
    SORBITOL
    PHENOXYETHANOL
    METHYLPARABEN
    ETHYLPARABEN
    BUTYLPARABEN
    PROPYLPARABEN
    ISOBUTYLPARABEN
    SODIUM LACTATE
    ZINC PCA
    POLYSORBATE 80
    BENZYL ALCOHOL
    METHYLCHLOROISOTHIAZOLINONE
    METHYLISOTHIAZOLINONE
    TRIETHYLENE GLYCOL
    MAGNESIUM NITRATE
    MAGNESIUM CHLORIDE
    TETRASODIUM EDTA
    SALICYLIC ACID
    PANTHENOL
    ALLANTOIN
    YELLOW FIVE
    ALCOHOL DENAT.
    IMIDAZOLIDINYL UREA
    CITRIC ACID Close
  • INGREDIENTS AND APPEARANCE
    PREPARING TONIC 
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51830-054
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1.8 mg  in 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    SORBITOL  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    ISOBUTYLPARABEN  
    SODIUM LACTATE  
    POLYSORBATE 80  
    BENZYL ALCOHOL  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    TRIETHYLENE GLYCOL  
    PROPYLENE GLYCOL  
    MAGNESIUM NITRATE  
    MAGNESIUM CHLORIDE  
    EDETATE SODIUM  
    METHYLPARABEN SODIUM  
    PANTHENOL  
    ALLANTOIN  
    FD&C YELLOW NO. 5  
    IMIDUREA  
    CITRIC ACID MONOHYDRATE  
    ZINC PIDOLATE  
    ALCOHOL  
    URTICA DIOICA LEAF  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51830-054-07 180 mg in 1 BOX
    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)
    Establishment
    Name Address ID/FEI Business Operations
    Lange SAS 275956105 manufacture(51830-054)
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