BALANSE NYC HAND SANITIZER- ethyl alcohol liquid

BALANSE NYC HAND SANITIZER by

Drug Labeling and Warnings

BALANSE NYC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by YASHVIRE LLC, MARSHALLS TRADITIONAL HEALTHCARE CC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Place enough product in your palm to spread on both hands.
• Rub your hands together thoroughly until dry.
• Children under 6 years of age should be supervised by an adult when using this product to avoid swallowing.

Inactive ingredients

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

Product Label

INGREDIENTS AND APPEARANCE

BALANSE NYC HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74094-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74094-001-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - YASHVIRE LLC (117396744)

Establishment
Name	Address	ID/FEI	Business Operations
MARSHALLS TRADITIONAL HEALTHCARE CC		637662219	manufacture(74094-001)