Label: CARIBBEAN MIST 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 March 22, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Isopropyl Alcohol 75%

  • PURPOSE

    Antimicrobial

  • USES

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • 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 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.

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

  • DIRECTIONS

    ■ 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

    ■ Store between 15-30C (59-86F)

    ■ Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENTS

    Glycerin, Hydrogen Peroxide, Purified Water USP.

  • QUESTIONS OR COMMENTS?

    1-800-758-1880.

  • CARIBBEAN MIST HAND SANITIZER 30 mL (NDC 81695-030-00)

    Caribbean Mist Hand Sanitizer 30 mL

  • INGREDIENTS AND APPEARANCE
    CARIBBEAN MIST HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81695-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81695-030-0030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/22/2021
    Labeler - B & B PRODUCTS MANUFACTURING LLC (842949161)
    Registrant - B & B PRODUCTS MANUFACTURING LLC (842949161)
    Establishment
    NameAddressID/FEIBusiness Operations
    B & B PRODUCTS MANUFACTURING LLC842949161manufacture(81695-030)
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