ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]

ULTRA GLOW FADE WITH ALOE VERA (HYDROQUINONE, PADIMATE O) CREAM [KEYSTONE LABORATORIES]
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NDC 58318-002-01
Set ID c0cc6cd4-8dea-4615-b763-2733f1582a66
Category HUMAN OTC DRUG LABEL
Packager Keystone Laboratories
Generic Name
Product Class
Product Number
Application Number PART358A
  • ACTIVE INGREDIENT

    Active Ingredient: 2% Hydroquinone, 1.5% Padimate O

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Skin lightener

  • INDICATIONS & USAGE

    Ultra Glow Fade Cream with Aloe Vera

  • WARNINGS

    Caution: Discontinue use of this product if skin irritation occurs or is already present. Do not use on children under 12 years of age. Avoid contact with eyes or consumption. Administer a patch test on a small area of the skin before applying cream to larger areas of the skin.

    Precautions d'emploi: Cesser l'utilisation du produit en cas d'irritation ou sur une peau deja irritee. Ne pas appliquer sur les enfants de moins de 12 ans. Eviter le contact avec les yeux et ne pas avaler. Realiser un test sur une zone reduite de la peau avand d'appliquer la creme sur des zones plus etendues.

  • DOSAGE & ADMINISTRATION

    Directions:Apply a small amount on the discolored or affected area twice daily. Results may vary; however, desired results are typically visibile within two weeks of usage. If no improvement is visible within 90 days of treatment, discontinue use of this product.

    Conseils d'application: Pour un maximum de resultat, appliquer une petite quantite de creme deux foix par jour sur les zones decolorees ou abimees. Les resultats peuvent varier et sont en general visibles apres deux semaines d'utilisation. En l'absence d'ameliorations visibles dans les 90 jours de traitement, interrompre l'application du produit.

  • OTHER SAFETY INFORMATION

    KEYSTONE LABORATORIES © 2012

    www.keystone-labs.com

    1-800-772-8860

    Memphis, TN 38101-2026

    NW7 3SA London, United Kingdom

    MADE IN U.S.A. / FABRIQUE AUX E.-U.

    PM-TB 0028

  • INACTIVE INGREDIENT

    Other Ingredients:

    aqua/water/eau, stearyl steareth, glycerol stearate, propylene glycol, cetyl alcohol, isopropyl myristate, ethylhexyl dimethyl, paraffinum liquidum/mineral oil/huile minerale, sodium metabisulfite, fragrance, steareth 20, methylparaben, tetrsodium edta, sodium sulfite, propylis gallas, methyl alcohol, propylparaben, citric acid, aloe barbadensis (leaf juice).

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ULTRA GLOW FADE  WITH ALOE VERA
    hydroquinone, padimate o cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58318-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1 g  in 57 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM DITHIONATE (UNII: RPF7Z41GAW)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58318-002-0157 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A04/07/1964
    Labeler - Keystone Laboratories (007017429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Laboratories007017429manufacture(58318-002)

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