Label: HAND SANITIZER 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 December 31, 2020

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  • Active Ingredient

    Isopropyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on skin
    • Recommended for repeated use
  • Warning

    • For External use only.
    • When using this product avoid contact with eyes. in case of eye contact, flush eyes with water.
    • Stop use and ask doctor if irritation or redness developed, or if condition persists for more than 72 hours.
    • Keep out of the reach of children.
    • If swallowed, get medical help or contact a poison control center immediately.

    For external use only.

    When using this product avoid contact with eyes. in case of eye contact, flush eyes with water.

    Stop use and ask doctor if irritation or redness developed, or if condition persists for more than 72 hours.

    Keep out of the reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    • place a small amount into palm.
    • rub thoroughly over all surfaces of both hands.
    • rub hands together briskly until dry.
  • Inactive Ingredients

    Deionized water, Cellulose

  • Drug Facts

    2 oz Hand sanitizer labels

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73768-372(NDC:73749-101)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73768-372-180.059 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    2NDC:73768-372-220.118 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    3NDC:73768-372-523.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2020
    Labeler - Mastitis Management Tools, Inc. (626863166)
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