Label: HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- 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 December 14, 2020

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  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reduce bacteria on the skin. • recommended for repeated use

  • Warnings

    • Flammable • Keep away from fire or flame • For external use only

  • When using this product

    • avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

  • Keep out of reach of children

    Children should only use this product under adult supervision.

    Do not drink. Not edible in case of accidental ingestion seek professional assistance or contact a Poison Control Center right away.

  • Other information

    •do not store above 105F. May discolor some fabrics • harmful to wood finishes and plastics

  • Directions

    •place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry • recommended for repeated use.

  • Inactive ingredients

    caprylyl glycol, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, tocopheryl acetate, triethanolamine, water.

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-503
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-503-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/31/2012
    2NDC:55319-503-10295 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/31/2012
    3NDC:55319-503-173 in 1 BLISTER PACK08/31/2012
    3NDC:55319-503-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:55319-503-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2012
    5NDC:55319-503-331000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2012
    Labeler - Family Dollar Services Inc. (024472631)
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