Label: AMORAY PREMIUM INSTANT HAND SANITIZER- 3k9958v90m liquid

  • 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 January 29, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% ......................... Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product

    Back Label

  • INACTIVE INGREDIENT

    Inactive Ingredients water, triethanolamine, glycerin, carbomer, PEG-40 hydrogenated castor oil, propylene gylcol, fragrance, tocopheryl acetate

    Inactive Ingredients

  • WARNINGS

    For External Use Only:

    Flammable. Keep away from fire or flame.

    Do not apply around eyes. Do not use in ears or mouth

    When using this product, avoid contact with eyes. In cases of contact flush eyes with water

    Stop Use and ask doctor if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.Children must be supervised in use of this product.

    Warnings

  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms and thouroughly spreand on both hands - rub into skin until dry.

  • INDICATIONS & USAGE

    Use Hand Sanitizer to decrease bacteria on the skin. - when water, soap & towel are not available. - Reccomended for repeated use

    Uses

  • PURPOSE

    hand sanitizer to help decrease bacteria on the skin. - when water, soap & towel are not available. - reccomended for repeated use.

    Purpose

  • PRINCIPAL DISPLAY PANEL

    Principal Package Label

  • INGREDIENTS AND APPEARANCE
    AMORAY PREMIUM INSTANT HAND SANITIZER 
    3k9958v90m liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73580-4220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL250 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73580-4220-5250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/07/2020
    Labeler - SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI (365908917)
    Registrant - SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI (365908917)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI365908917manufacture(73580-4220)
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