Safe Sanitize Hand Sanitizer

Safe Sanitize Hand Sanitizer by

Drug Labeling and Warnings

Safe Sanitize Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Eksa Mills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE SANITIZE HAND SANITIZER- alcohol gel 
Eksa Mills, S.A. de C.V.

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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Safe Sanitize Hand Sanitizer

Active ingredient

Ethyl Alcohol 70% 

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.
Recommended for repeated use.

Warnings

For external use only. 

Flammable, keep away from heat and flame.

Do not use

in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children.

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

Directions

- wet hands thoroughly with product - brisky rub hands together until dry - supervise children under 6 years in the use of the product.

Other Information

Store at 69°F to 77°F (20° C to 25° C). May discolor certain fabrics.

Inactive Ingredients

water, glycerin, thickener.

Package Labeling:

SAFE SANITIZE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77538-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77538-004-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2020	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/28/2020	01/28/2020

Labeler - Eksa Mills, S.A. de C.V. (951573231)

Revised: 4/2022

Document Id: dd061976-a819-aad1-e053-2995a90abaad

34390-5

Set id: ab8520f5-630c-2eb2-e053-2a95a90aadd5

Version: 3

Effective Time: 20220419