Label: MEDICALLY MINDED- 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 April 29, 2020

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  • Active Ingredient(s)

    activeAlcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial Purpose, Hand Sanitizer

  • Use

    USAGEHand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • Do not
      in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    usingWhen using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • dosage
      Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    water. TRIETHANOLAMINE LAURYL SULFATE, carbomer inactive

  • Package Label - Principal Display Panel

    4 front000 ml Hand Sanitizer Gel

  • INGREDIENTS AND APPEARANCE
    MEDICALLY MINDED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76619-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) 0.0004 mL  in 1 mL
    CARBOMER 934 (UNII: Z135WT9208) 0.004 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.2956 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76619-110-034000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/26/2020
    Labeler - SBL LLC (117341346)
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