SIMPLY SAFER HAND SANITZER- alcohol gel

Simply Safer hand sanitzer by

Drug Labeling and Warnings

Simply Safer hand sanitzer by is a Otc medication manufactured, distributed, or labeled by Simply Safer Products Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

on children less than 2 months of age

on open skin wounds

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry
• Supervise children under 6 years of age when using product to avoid swallowing

Other information

• Store between 15-30C (59-84F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Deionized Water, Glycerol, Carbomer, Triethanolamine

Package Label - Principal Display Panel

3 mL NDC: 79754-001-01

INGREDIENTS AND APPEARANCE

SIMPLY SAFER HAND SANITZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79754-001(NDC:56084-021)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79754-001-01	3 mL in 1 BAG; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020

Labeler - Simply Safer Products Llc (117579462)