Label: AHC WHITENING SPECIAL GEN CREAM- niacinamide cream 

  • Label RSS
  • 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
    DIPROPYLENE GLYCOL
    HYDROGENATED POLYDECENE (550 MW)
    CETYL ETHYLHEXANOATE
    DODECAMETHYLPENTASILOXANE
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS
    CETOSTEARYL ALCOHOL
    ARACHIDYL ALCOHOL
    DIMETHICONE
    CYCLOMETHICONE
    POLYSORBATE 60
    LIMNANTHES ALBA WHOLE
    DOCOSANOL
    PANTHENOL
    ARACHIDYL GLUCOSIDE
    SORBITAN SESQUIOLEATE
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
    PALMITIC ACID
    STEARIC ACID
    PHENOXYETHANOL
    .ALPHA.-TOCOPHEROL ACETATE
    CHLORPHENESIN
    ORYZA SATIVA WHOLE
    ETHYLHEXYLGLYCERIN
    CAPRYLYL GLYCOL
    ROSA CANINA FRUIT OIL
    GRAPE SEED OIL
    XANTHAN GUM
    SALVIA OFFICINALIS FLOWERING TOP
    CAMELLIA SINENSIS WHOLE
    PROPYLENE GLYCOL
    EDETIC ACID
    HYALURONATE SODIUM
    PANTOLACTONE, (+/-)-
    SORBITOL
    GINKGO BILOBA LEAF OIL
    USNEA BARBATA
    PRUNUS MUME FRUIT
    ZANTHOXYLUM PIPERITUM FRUIT PULP
    PULSATILLA KOREANA WHOLE
    LECITHIN, SOYBEAN
    SODIUM ASCORBYL PHOSPHATE
    ASCORBYL GLUCOSIDE

    Fragnance

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AHC WHITENING SPECIAL GEN CREAM 
    niacinamide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58930-051
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 0.6 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    1,3-BUTYLENE GLYCOL  
    GLYCERIN  
    DIPROPYLENE GLYCOL  
    HYDROGENATED POLYDECENE (550 MW)  
    CETYL ETHYLHEXANOATE  
    DODECAMETHYLPENTASILOXANE  
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS  
    CETOSTEARYL ALCOHOL  
    ARACHIDYL ALCOHOL  
    DIMETHICONE  
    CYCLOMETHICONE  
    POLYSORBATE 60  
    LIMNANTHES ALBA WHOLE  
    DOCOSANOL  
    PANTHENOL  
    ARACHIDYL GLUCOSIDE  
    SORBITAN SESQUIOLEATE  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)  
    PALMITIC ACID  
    STEARIC ACID  
    PHENOXYETHANOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    CHLORPHENESIN  
    ORYZA SATIVA WHOLE  
    ETHYLHEXYLGLYCERIN  
    CAPRYLYL GLYCOL  
    ROSA CANINA FRUIT OIL  
    GRAPE SEED OIL  
    XANTHAN GUM  
    SALVIA OFFICINALIS FLOWERING TOP  
    CAMELLIA SINENSIS WHOLE  
    PROPYLENE GLYCOL  
    EDETIC ACID  
    HYALURONATE SODIUM  
    PANTOLACTONE, (+/-)-  
    SORBITOL  
    GINKGO BILOBA LEAF OIL  
    USNEA BARBATA  
    PRUNUS MUME FRUIT  
    ZANTHOXYLUM PIPERITUM FRUIT PULP  
    PULSATILLA KOREANA WHOLE  
    LECITHIN, SOYBEAN  
    SODIUM ASCORBYL PHOSPHATE  
    ASCORBYL GLUCOSIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58930-051-01 1 in 1 CARTON
    1 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/15/2013
    Labeler - Carver Korea Co.,Ltd (688442290)
    Registrant - Jemian USA Inc. (078822273)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmecca Korea Co.,Ltd. 688830827 manufacture(58930-051)
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