ALCOHOL- alcohol spray 
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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.

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DRUG FACTS

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

  • 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.

OTHER INFORMATION:

Store between 15-30C (59-86F)

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
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)

Revised: 2/2021
Document Id: 38401533-93d4-499f-872f-fb560f24d292
Set id: 81bdd5e0-dd41-4fec-ae25-e0129b4048ee
Version: 1
Effective Time: 20210209
 
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