Label: AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E LAVENDER- alcohol gel

  • NDC Code(s): 40104-421-01
  • Packager: Ningbo Pulisi Daily Chemical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 16, 2015

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  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Ethyl Alcohol                62%      ...        Antiseptic

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  • PURPOSE

    Hand sanitizer to help decrease bacteria on the skin.

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  • KEEP OUT OF REACH OF CHILDREN

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

    Children must be supervised in use of this product.

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  • INDICATIONS & USAGE

    keep out of eyes

    when water, soap and towel are not available

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  • WARNINGS

    For external use only.
    Flammable. Keep away from hear or flame.

    Do not apply around eyes; Do not use in ears and mouth. When using this products, avoid contact with eyes. In case of contact, flush eyes with water.

    Stop using and ask a doctor, if irritation and redness develops, if condition persists for more than 72 hours, consult a doctor.

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  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms and thoroughly spread on both hands, and rub the skin until dry.

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  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance

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  • INGREDIENTS AND APPEARANCE
    AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E  LAVENDER
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:40104-421
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:40104-421-01 237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/16/2015
    Labeler - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(40104-421)
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