Label: HAND SANITIZER- alcohol liquid

  • 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 July 29, 2020

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  • Uses

    Uses

    * Helps eliminate bacterias on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

  • Active Ingredient

    Active Ingredient Purpose

    • Ethyl Alcohol 68%...................................Antiseptic
  • Warnings

    • For external use only-
    • When using this product keep out o f eyes. In case of contact, flush with water several minutes.
    • Keep out of reach of children except under adult supervision
    • If swalow get medical help or contact a Poison Control Center right away.
    • Flammable: Keep away from heat and flame.
    • Stop use and ask Doctor: if skin irritation develops.
    • Do not swalow
    • Children under 6 years old should be supervised when using this product

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    * Irritation develops

  • Keep out of reach of children

    Keep out of reach of children. In case of incidental ingestion, see professional advice or contact a Poison Control Center inmediately.

  • Directions

    Directions:

    • Place enough product in your palm to throughly cover your hands.
    • Rub hands together briskly until dry
    • Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry
  • Inactive Ingredients

    Water, citric acid, glycerine, propylene glycol

  • Questions?

    QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

  • Uses

    Uses

    * Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

  • Hand Sanitize

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79894-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79894-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2020
    Labeler - SAMARA COSMETICS S.A.S. (881793172)
    Registrant - SAMARA COSMETICS S.A.S. (881793172)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMARA COSMETICS S.A.S.881793172manufacture(79894-002)
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