Label: HAND SANITIZER- 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 July 10, 2020

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  • Active Ingredients

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose: Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin.

  • Warnings

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

  • Do not use

    • in the eyes
  • STOP USE

    Stop use and ask a doctor if irritation and redness develop. Condition persists for more than 72 hours.

  • 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

    • Wet hands thoroughly with product and allow to dry without wiping
  • Other information

    • Store between 59-86ºF (15-30ºC)
    • Avoid freezing and excessive heat above (40ºC) 104ºF
  • Inactive ingredients

    Carbomer, glycerin, fragrance, triethanolamine, water, zinc oxide, zinc pyrithione

  • PRINCIPAL DISPLAY PANEL

    200000 mL NDC 69912-009-06

    200L

    60 mL NDC 69912-009-05

    60mL

    500 mL NDC 69912-009-03

    500mL

    250 mL NDC 69912-009-04

    250mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69912-009
    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
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69912-009-06200000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    2NDC:69912-009-0560 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    3NDC:69912-009-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    4NDC:69912-009-04250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - Nanomateriales, S.A. de C.V. (812756920)
    Registrant - Nanomateriales, S.A. de C.V. (812756920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanomateriales, S.A. de C.V.812756920manufacture(69912-009) , pack(69912-009) , label(69912-009)
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