Label: SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH- ethyl alcohol liquid

  • NDC Code(s): 12745-850-01, 12745-850-02, 12745-850-03
  • Packager: Medical Chemical Corporation
  • 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 October 16, 2020

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  • Purpose

    Germicide

  • Active Ingredients

    Ethyl Alcohol 70% v/v

  • Inactive Ingredients

    Purified water, Emollients (Laurel, Myristal and Cetyl Lactate,), Aloe Vera, Carbomer, Parabens, Diisopropylamine

  • Warnings

    Warnings: Flammable, keep away from fire or flame.  For external use only.  Do no use in the eyes.  Discontinue use if irritation or redness develops.  Keep out of reach of children.  In case of ingestion contact poison control center immediately.

  • Warnings

    Danger: Highly flammable liqid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.

  • Directions

    Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.

  • Uses

    Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.

  • PRINCIPAL DISPLAY PANEL

    spectragenixlabel.jpg

    spectragenixlabel

  • INGREDIENTS AND APPEARANCE
    SPECTRAGENIX HAND SANITIZER  ANTISEPTIC HAND WASH
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL55.34 g  in 100 mL
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4) DIAZOLIDINYL UREA0.167 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ) 0.02 g  in 100 mL
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 4 g  in 100 mL
    CETYL LACTATE (UNII: A7EVH2RK4O) 0.5 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 mL
    DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.29 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12745-850-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
    2NDC:12745-850-02946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
    3NDC:12745-850-033785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/23/2020
    Labeler - Medical Chemical Corporation (008496861)
    Registrant - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-850)
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