BALANSE NYC HAND SANITIZER- ethyl alcohol liquid 
YASHVIRE LLC

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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BALANSE NYC

Active lngredient  

Ethyl Alcohol 70%

Purpose 

Antiseptic 

Uses 

Hand sanitizer to help decrease bacteria on the skin. When water, soap and towel are not available. Recommended for repeated use

Warnings:

For external use only.
Flammable. Keep away from fire or flame
Do not apply around eyes. Do not use in ears & mouth
Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Keep out of reach of children.

Children must be supervised in use of this product

Directions

Inactive ingredients

Aqua, Glycerine, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate

Product Label

image description

BALANSE NYC HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74094-001
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74094-001-01500 mL in 1 BOTTLE, PUMP; 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
Labeler - YASHVIRE LLC (117396744)
Establishment
NameAddressID/FEIBusiness Operations
MARSHALLS TRADITIONAL HEALTHCARE CC637662219manufacture(74094-001)

Revised: 4/2020
Document Id: 8a35a6d7-98af-4478-98af-d8dc93cbb611
Set id: 265d12f3-0f12-4f64-98b4-ca7c0a98ac59
Version: 1
Effective Time: 20200402
 
YASHVIRE LLC