Label: SANIMAX- alcohol cloth

  • 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 June 26, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 75% v/v.

  • Purpose

    Antiseptic

  • Use

    decreases bacteria on skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

    When using the product

    • keep out of eyes, in case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest
    • do not reuse wipe
    • do not flush in toilet

    Stop use and ask a doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Wipe down surface thoroughly and allow to air-dry.
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • Other information

    • do not store above 105°F
  • Inactive ingredients

    purified water, glycerin. aloe barbadensis extract, phenoxyethanol, ethylhexlyglycerin, propylene glycol

  • Product Labels

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SANIMAX 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79308-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79308-001-0180 in 1 CANISTER05/22/2020
    14.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:79308-001-0280 in 1 CANISTER05/22/2020
    24.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:79308-001-0380 in 1 CANISTER05/22/2020
    34.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2020
    Labeler - SYNDICATE ONE GROUP INC (117555403)