Fresh N Pure Hand Sanitizer: Package Insert and Label Information

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.

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:

Bottle
(click image for full-size original)

FRESH N PURE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81501-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81501-000-01 500 mL in 1 BOTTLE None
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)

Revised: 02/2021 Sai Water & Technology Solution LLC

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