Label: NATURAL CONCEPTS HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E FRESH SCENT- ethyl alcohol gel

  • 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 March 16, 2020

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  • Active ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • to help reduce bacteria on the skin.
  • Warnings

    For external use only

    • Flammable. Keep away from heat or flame.

    When using thi sproduct

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop useing and ask a doctor if

    • irritation or rash appears and lasts.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply a small amount to your palm and rub hands together briskly until dry.
    • Children under 6 should be supervised when using this product.
  • Other information

    Do not store above 110°F (43°C)

  • Questions / comments?

    1-866-695-3030

  • Inactive ingredients

    Water (Aqua), Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance (Parfum).

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    NATURAL CONCEPTS HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E  FRESH SCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-224-401180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/13/2020
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-224)
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