Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

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

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 this product to avoid swallowing.

Other information

Store between 59ºF-86ºF (15ºC-30ºC)
Avoid freezing and excessive heat above 104ºF (40ºC)

Inactive ingredients

Carbomer, Glycerin, Purified water, Trolamine

Package Label - Principal Display Panel

3780 mL NDC: 78361-003-01

3780ml label
1000 mL NDC: 78361-003-02
1000ml front label 1000ml back label
500 mL NDC: 78361-003-03
500ml front label 500ml back label
250 mL NDC: 78361-003-04
250ml front label 250ml back label
330 mL NDC: 78361-003-05
330ml front label 330ml back label
60 mL NDC: 78361-003-06
60ml label

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78361-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.4 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78361-003-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC:78361-003-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC:78361-003-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC:78361-003-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
5	NDC:78361-003-05	330 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
6	NDC:78361-003-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/01/2020

Labeler - Diquisa, S.A. De C.V. (815736509)

Name	Address	ID/FEI	Business Operations
Establishment
Diquisa, S.A. De C.V.		815736509	manufacture(78361-003)