CUIR HAND SANITIZER- alcohol gel
Comercial Riley 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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CUIR Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease.
For use when water soap & towel are not available.

Warnings

Flammable, Keep away from heat or flame.

For external use only.

Do not use

In or near the eyes. In case of contact, rinse eyes thoroughly with water.
On children less than 2 months of age.
On open skin wounds.

Stop use and ask a physician,

if irritation or rash appears and lasts.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children less than 6 years of age when using this product to avoid swallowing.
If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store between 59-86°F (15-30°C).
Avoid freezing and excessive heat above 104°F (40°C).

Inactive ingredients

Glycerin, hydrogen peroxide, purified water (USP)

Package Labeling:

Bottle

Package Labeling:

Bottle2

CUIR HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78514-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78514-001-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
2	NDC:78514-001-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/18/2020

Labeler - Comercial Riley S.A. de C.V. (951578468)