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 Ingredient

Ethyl alcohol v/v- 60-80%

Purposes

Antimicrobial

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease

Recommended for repetead use

Warnings

For external use only: hands

Flammable, keep away form fire and flame

When using this product

keep out of ayes, do not use in or near the eyes

In case of contact with eyes, flush thorougly with water

Avoid contact with broken skin

Do not inhale or ingest

When using this product

keep out of ayes, do not use in or near the eyes

In case of contact with eyes, flush thorougly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop use and ask a doctor if

Irritation and redness develop

Condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a poison center right away

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

for children under 6 years of age should be supervised when using

not recommended for infants

Other information

Store below 105 F 40C

Mary discolour certain fabrics

harmful to wood finishes and plastics

Inactive ingredients

Purified water (aqua), vegetable glycerin, carboxymethyl cellulose, hydroxypropyl methylcellulose HPMC, and pepper mint oild and vitamine E

Principal display

Natural ingredients

Mint

Hand sanitizer gel

eliminates 99.9% of germs

vitamine E hands soft

contain mosturizers

*e coli and S. areus

HO3

parabens

methanol

formaldehyde

triethanolamine

carbopol

free

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80535-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80535-0001-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020
2	NDC: 80535-0001-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020
3	NDC: 80535-0001-3	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

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	label(80535-0001) , pack(80535-0001) , manufacture(80535-0001)