Label: PROTECT HAND SANITIZER- isopropyl 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 January 6, 2022

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    • Hand Sanitizer to help reduce bacteria that potentially can cause disease.
    • When hand wahing, water & soap are not available
    • recommended for repeated use.
  • Warnings

    For external use only. Flammable. Keep away from heat or flame. Do not apply around eyes.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

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

  • 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

    • pump or spray a small amount into your palms, and rub lightly into hands
    • let air dry
  • Other information

    • store at 20C (68 to 77F)
    • may discolor fabrics
  • Inactive ingredients

    vegtable glycerin, aloe barbadensis (alow vera) juice, hydrogen peroxide, citrus aurantium dulcis (orange) peel oil, azadirachta indica (neem) extract, rosemarinus officinalis (rosemary) oil, carbomer

  • Package Label - Principal Display Panel

    label 2label

  • INGREDIENTS AND APPEARANCE
    PROTECT HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74110-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEMON OIL (UNII: I9GRO824LL)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74110-001-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    2NDC:74110-001-027 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/202004/15/2020
    3NDC:74110-001-03100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Dr. Brite (079902543)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Brite079902543manufacture(74110-001)
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