FRESH N PURE HAND SANITIZER- alcohol gel

Fresh N Pure Hand Sanitizer by

Drug Labeling and Warnings

Fresh N Pure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sai Water & Technology Solution LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Ethyl Alcohol 70% v/v

Purpose:

Antimicribial

Uses:

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings:

Flammable. Keep away from fire or flames.

When using this product 

do not use in or near eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor 

if irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control Center right away.

Directions:

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using sanitizer.

Other Information:

• Store below 110°F (43°C) 
• May discolor some fabrics or surfaces.

Inactive Ingredients:

Purified Water(Aqua), Carbomer, Glycerin, Propylene Glycol, Isopropyl Alcohol, Fragrance (Lemon), Triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

FRESH N PURE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81501-000
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81501-000-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/04/2021

Labeler - Sai Water & Technology Solution LLC (117138209)