Label: ALCOMAX- 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 November 25, 2020

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  • Active Ingredient

    ALCHOL 70%

  • PURPOSE

    ANTIMICROBIAL

  • Inactive Ingredient

    Water, Aloe Barbadensis leaf, chamaecyparis Obtusa leaf, Glycerin, Carbomer, Arqinine, DISODIUM EDTA

  • Direction

    Place enough product on hands to cover all surfaces.Rub hands together until dry.

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

  • 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 whit water.

  • Warnings

    for external sue only. Flammable. keep away from heat or flame

  • Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control center right away.

  • Stop use and ask a doctor.

    if irritationor rash occurs. These may be signs of a serious contion.

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not avaliable.

  • Other information

    Store between 33.8~86'F

    Avoid freezing and excessive heat

  • Pakage Label

    ​3.7L 75700-301-04

    100ml 75700-301-03

    500ml 75700-301-02 (new)

    500ml 75700-301-01

    1gal label(3.7L)

    100ml label

    new label image 500ml

    500ml NDC:75700-301-01 Label

  • INGREDIENTS AND APPEARANCE
    ALCOMAX 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75700-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 2.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) 2 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 3.5 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) 4 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 13 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75700-301-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/23/2020
    2NDC:75700-301-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
    3NDC:75700-301-03100 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2020
    4NDC:75700-301-043700 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - CONIC CO., LTD. (695625917)
    Registrant - CONIC CO., LTD. (695625917)
    Establishment
    NameAddressID/FEIBusiness Operations
    CONIC CO., LTD695625917manufacture(75700-301)
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