BREATHE HAND SANITIZER GEL- alcohol gel 
Blue Cross Laboratories, Inc.

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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Breathe Hand Sanitizer Gel

Active Ingredient(s)

Ethyl alcohol 70% Purpose: Antiseptic

Purpose

Antiseptic

Use

Warnings

For external use only- hands

Flammable. Keep away from heat or flame

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin. do not inhale or ingest.


Stop use and ask a doctor if irritation develops

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

Directions

Other information

Inactive ingredients

water, glycerin, fragrance, carbopol, triethanolamine

Package Label - Principal Display Panel

breathe Hand Sanitizer Gel

8 FL OZ (236 mL)

Breathe Hand Santizer

BREATHE HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-010-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/06/2020
Labeler - Blue Cross Laboratories, Inc. (008298879)
Establishment
NameAddressID/FEIBusiness Operations
Blue Cross Laboratories, Inc.008298879manufacture(22431-010)

Revised: 10/2020
Document Id: b102fc86-1640-3595-e053-2a95a90a332b
Set id: b102f8d7-a9c9-393e-e053-2a95a90a9cd0
Version: 1
Effective Time: 20201006
 
Blue Cross Laboratories, Inc.