Label: MEDI FECT ANTISEPTIC HAND WASH- ethyl alcohol liquid

  • 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 17, 2022

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  • PURPOSE

    Indications for use: For hospital and professional use only.  Medi-Fect is intended to be used as a hand-wash to reduce bacteria that can potentially cause disease. Recommended for repeated use.

  • ACTIVE INGREDIENT

    Ingredients: 70% v/v ethyl alcohol, propylene glycol, emolients (polysorbate 80, cetyl alcohol, acetylated lanolin alcohol), carbomer, diazolidinyl urea, methyl paraben, aloe vera and propyl paraben. Contains emollients and skin conditioners. Contains no added fragrance or dyes.

  • INACTIVE INGREDIENT

    Ingredients: 70% v/v ethyl alcohol, propylene glycol, emolients (polysorbate 80, cetyl alcohol, acetylated lanolin alcohol), carbomer, diazolidinyl urea, methyl paraben, aloe vera and propyl paraben. Contains emollients and skin conditioners. Contains no added fragrance or dyes.

  • KEEP OUT OF REACH OF CHILDREN

    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

    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.

  • DOSAGE & ADMINISTRATION

    Directions: Place a 'palmful' (about 5 g) of product in one hand.  Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).  Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into skin until dry (approximately 30 seconds).

  • INDICATIONS & USAGE

    Indications for use: For hospital and professional use only.  Medi-Fect is intended to be used as a hand-wash to reduce bacteria that can potentially cause disease. Recommended for repeated use.

  • PRINCIPAL DISPLAY PANEL

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    medifectlabel

  • INGREDIENTS AND APPEARANCE
    MEDI FECT  ANTISEPTIC HAND WASH
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL59.86 g  in 100 mL
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4) DIAZOLIDINYL UREA1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.5 g  in 100 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.5 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 mL
    DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.505 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12745-177-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    2NDC:12745-177-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    3NDC:12745-177-033785 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package05/14/2001
    4NDC:12745-177-0418927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    5NDC:12745-177-0559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    6NDC:12745-177-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    7NDC:12745-177-07946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
    8NDC:12745-177-08208198 mL in 1 DRUM; Type 0: Not a Combination Product05/14/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/14/2001
    Labeler - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-177)
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