Label: ALCOHOL spray

  • 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 February 9, 2021

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  • ACTIVE INGREDIENT(S)

    Alcohol 80% v/v.

  • PURPOSE

    Antiseptic

  • USE(S):

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

    • Stop use and ask 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.
  • 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

  • Principal Display Panel – 59 mL Bottle Label

    Non-sterile Solution

    hello
    bello™

    Alcohol Antiseptic 80
    Topical Solution

    Hand Sanitizer
    Spray

    2 fl. oz. (59 ml) e

    Principal Display Panel – 59 mL Bottle Label
  • Principal Display Panel – 59 mL Bottle Label

    hello
    bello™

    Apple Blossom

    62.5% Alcohol

    Hand Sanitizer
    Spray

    2.0 fl. oz. (59 ml) e

    Principal Display Panel – 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-042-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    ALCOHOL 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Panthenol (UNII: WV9CM0O67Z)  
    Allantoin (UNII: 344S277G0Z)  
    Avocado (UNII: SDS87L369F)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Cucumber (UNII: YY7C30VXJT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-043-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2020
    Labeler - Hello Bello (081135707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unconditional Love081135707MANUFACTURE(73418-042, 73418-043)
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