FRESH N PURE HAND SANITIZER- alcohol gel 
Sai Water & Technology Solution 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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Fresh N Pure Hand Sanitizer

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:

Other Information:

Inactive Ingredients:

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

Package Labeling:

Bottle

FRESH N PURE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81501-000
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81501-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/04/2021
Labeler - Sai Water & Technology Solution LLC (117138209)

Revised: 2/2021
Document Id: bb1163e8-12a0-3216-e053-2a95a90a4049
Set id: bb1163e8-129f-3216-e053-2a95a90a4049
Version: 1
Effective Time: 20210211
 
Sai Water & Technology Solution LLC