HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by FARMACIA SAN ARCANGEL, S.A DE C.V, FARMACIA SAN ARCANGEL S.A DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

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

In 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 throrugly with water

Stop use and ask a doctor

if irritation or rash occurs. These maybe 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

Put 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 15-30C (58-86F)

Avoid freezing and excesive heat above 40C (104F)

Inactive ingredients

Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

Principal Display

Hand sanitizer

70% alcohol

68 fl. oz. (2.1qt) (2L)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80535-0002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80535-0002-1	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2020

Labeler - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)

Registrant - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)

Establishment
Name	Address	ID/FEI	Business Operations
FARMACIA SAN ARCANGEL S.A DE C.V		951583068	manufacture(80535-0002) , label(80535-0002) , pack(80535-0002)