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 March 10, 2021

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Recommended for repeated use.

    For handwashing to decrease bacteria on the skin.

  • Warnings

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

  • Do not use

    • in the eyes. In case of contact, rinse eyes thoroughly with water
  • WHEN USING

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

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • We hands thoroughly with product
    • Brisky rub hands together until dry
    • Supervise children under 6 years in the use of this product.
  • Other information

    • May discolor certain fabrics
    • Store at the normal temperature
  • Inactive ingredients

    aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

  • Package Label - Principal Display Panel

    100 mL NDC: 81650-100- 01

    81650-100-01

    250 mL NDC: 81650-100- 02

    81650-100-02

    500 mL NDC: 81650-100- 03

    81650-100-03

    1000 mL NDC: 81650-100- 04

    81650-100-04

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81650-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.02 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.19 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.33 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.15 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.41 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 20.78 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81650-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
    2NDC:81650-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
    3NDC:81650-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
    4NDC:81650-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2021
    Labeler - SKYMAX VIETNAM COMPANY LIMITED (555655220)
    Registrant - SKYMAX VIETNAM COMPANY LIMITED (555655220)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKYMAX VIETNAM COMPANY LIMITED556548577manufacture(81650-100)
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