Label: ADORA- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 20, 2020

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  • Drug Facts

  • Active Ingredient

    Ethanol Alcohol 70% w/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses: Hand sanitizer to help reduce bacteria that can cause disease.

  • Warnings:

    For external use only. Flammable, Keep away from heat or flame.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    In case of eye contact flush thoroughly with water for at least 15 seconds.

    Keep out of reach of children. If swallowed, give copious amounts of water to dilute and seek medical attention immediately. Children age 6 and under should be supervised

  • DOSAGE & ADMINISTRATION

    Directions: Place enough on hands to cover all surfaces. Rub hands together until dry

  • STORAGE AND HANDLING

    Other Information: store between 15-30C (59-96F)
    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Propylene Glycol, Glycerine, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethyl Propanol, Fragrance

  • SPL UNCLASSIFIED SECTION

    FREE AND CLEAR

    MOISTURIZING GEL

    CONTAINS 70% ALCOHOL FORMULATED WITH BOTANICAL EXTRACTS

    Manufactured for Herbal Remedies, Inc. 1245 Hickory

    Chapel Rd. High Point, NC 27260

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ADORA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76842-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76842-700-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Adora (097969507)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adora097969507manufacture(76842-700)
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