Health N Hygiene Hand Sanitizer: Package Insert and Label Information

HEALTH N HYGIENE HAND SANITIZER- alcohol gel
Sai N.M. Ventures 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:

Antimicrobial

Uses:

Hand Sanitizer to reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

Warning:

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 certain fabrics or surfaces

Inactive Ingredients:

Purified Water(Aqua), Carbomer, Glycerin, Propylene Glycol.

Package Labeling:60ml

Label
(click image for full-size original)

Package Labeling:120ml

Label2
(click image for full-size original)

HEALTH N HYGIENE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80198-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80198-001-00 60 mL in 1 BOTTLE None
2 NDC:80198-001-01 120 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 10/14/2020
Labeler — Sai N.M. Ventures LLC (071969668)

Revised: 10/2020 Sai N.M. Ventures LLC

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