Label: MAGIC XTREME XTRA HAND SANITIZER- 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 January 15, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 72%

  • PURPOSE

    Antibacterial

  • USES

    Hand sanitizer to decrease bacteria on the skin.

  • WARNINGS

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

    Do not use

    ■ in children less than 2 months of age

    ■ on open skin wounds

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

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    ■ Wet hands thoroughly. Allow to dry without wiping.

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER INFORMATION

    ■ Store between 15-30C (59-86F)

    ■ Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENTS

    Carbopol, Glycerin, Triethanolamine, Water (Aqua).

  • QUESTIONS OR COMMENTS?

    1-855-349-7735 or visit www.eydmx.com

  • MAGIC XTREME XTRA HAND SANITIZER 2 mL (NDC 78885-002-00)

    Magic Xtreme Hand Sanitizer 2 mL

  • INGREDIENTS AND APPEARANCE
    MAGIC XTREME XTRA HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78885-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78885-002-002 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/15/2021
    Labeler - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)
    Registrant - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENSOBRETADOS Y DERIVADOS S.A. DE C.V.813382660manufacture(78885-002)
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