Label: SPARKLE- isopropyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 18, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 65% v/v. Purpose: Antiseptic

  • Use

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

  • Warnings

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

  • Do not use

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

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Other information

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

    glycerin, purified water, carbomer, triethanolamine, fragrance

  • 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.

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • Package Label - Principal Display Panel

    label64 fl oz, 1/2 gal NDC: 78541-1001-1

  • INGREDIENTS AND APPEARANCE
    SPARKLE 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78541-1001
    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
    CARBOMER 940 (UNII: 4Q93RCW27E) 2.5 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.95 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 24.6 mL  in 100 mL
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78541-1001-21893 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - NBA General Corporation INC (043707019)
    Establishment
    NameAddressID/FEIBusiness Operations
    NBA General Corporation INC043707019manufacture(78541-1001)
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