Label: AHC WHITENING SPECIAL GEN SOLUTION- niacinamide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 03/14

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

     Active Ingredients  Purpose
     Niacinamide 2.0%  Skin Protectant

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  • Uses

    Helps to improve skin firmness

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  • Warning

    For external use only

    do not use on damaged or broken skin

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control right away.

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  • INSTRUCTIONS FOR USE

    Apply small amount to a clean skin and massage gently with fingertips.

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  • DOSAGE & ADMINISTRATION

    Dosage: Small Amount

    Administration: apply to a clean skin and massage gently

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  • Inactive Ingredients

    WATER
    1,3-BUTYLENE GLYCOL
    GLYCERIN
    ALCOHOL
    PEG/PPG-17/6 COPOLYMER
    BETAINE
    PHENOXYETHANOL
    TROLAMINE
    CHLORPHENESIN
    CARBOMER 940
    PEG-60 HYDROGENATED CASTOR OIL
    ETHYLHEXYLGLYCERIN
    CAPRYLYL GLYCOL
    BENZOPHENONE-5
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)
    EDETIC ACID
    SUCROSE DISTEARATE
    HYALURONATE SODIUM
    PANTHENOL
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
    AMINO ACIDS, SILK
    LECITHIN, SOYBEAN
    POTASSIUM CETYL PHOSPHATE
    .ALPHA.-TOCOPHEROL ACETATE
    PULSATILLA KOREANA WHOLE
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)
    VITAMIN A PALMITATE
    BUTYLATED HYDROXYTOLUENE
    XANTHAN GUM
    ZANTHOXYLUM PIPERITUM FRUIT PULP
    USNEA BARBATA
    ACETYL HEXAPEPTIDE-8
    TARAXACUM OFFICINALE ROOT
    ORYZA SATIVA WHOLE
    CAMELLIA SINENSIS WHOLE
    SODIUM ASCORBYL PHOSPHATE
    D&C RED NO. 33
    ASCORBIC ACID

    Adenium Obesum Callus Culture Extract

    Fragnance 

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AHC WHITENING SPECIAL GEN SOLUTION 
    niacinamide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58930-053
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2.4 g  in 120 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    1,3-BUTYLENE GLYCOL  
    GLYCERIN  
    ALCOHOL  
    PEG/PPG-17/6 COPOLYMER  
    BETAINE  
    PHENOXYETHANOL  
    TROLAMINE  
    CHLORPHENESIN  
    CARBOMER 940  
    PEG-60 HYDROGENATED CASTOR OIL  
    ETHYLHEXYLGLYCERIN  
    CAPRYLYL GLYCOL  
    BENZOPHENONE-5  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)  
    EDETIC ACID  
    SUCROSE DISTEARATE  
    HYALURONATE SODIUM  
    PANTHENOL  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE  
    AMINO ACIDS, SILK  
    LECITHIN, SOYBEAN  
    POTASSIUM CETYL PHOSPHATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    PULSATILLA KOREANA WHOLE  
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)  
    VITAMIN A PALMITATE  
    BUTYLATED HYDROXYTOLUENE  
    XANTHAN GUM  
    ZANTHOXYLUM PIPERITUM FRUIT PULP  
    USNEA BARBATA  
    ACETYL HEXAPEPTIDE-8  
    TARAXACUM OFFICINALE ROOT  
    ORYZA SATIVA WHOLE  
    CAMELLIA SINENSIS WHOLE  
    SODIUM ASCORBYL PHOSPHATE  
    D&C RED NO. 33  
    ASCORBIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58930-053-01 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/10/2013
    Labeler - Carver Korea Co.,Ltd (688442290)
    Registrant - Jemian USA Inc. (078822273)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmecca Korea 688830827 manufacture(58930-053)
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