SANITIZER- alcohol liquid 
FARMACIA SAN ARCANGEL, 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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Active Ingredient

Isopropyl Alcohol 70% v/v

Purposes

Antimicrobial

Uses

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

Recommended for repetead use

Warnings

Flammable, keep away form fire or flame

For external use only: hands

For external use only: hands

When using this product

keep out of eyes, do not use in or near eyes.

In case of contact with eyes, flush thorougly with water

avoid contact with broken skin

do not inhale or ingest

Stop use or ask a doctor if

Irritation and redness develop and condition 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

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

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

Other information

Store below 105F (40C)

may discolour certain fabrics

harmful to wood finishes and plastics

Inactive ingredients

Purified water (aqua), vegetable glycerine, d-limonene and linalool as fragance

Principal Display

label 100 ml 70% Isopropyl hand sanitizer

Fresh scent

with terpene enhaced

antibacterial protection

kills 99% of bacteria and germs

70% isopropyl alcohol

no ethyl alcohol

no hudrogen peroxide

scented with natural terpenes

helps moisturize with glycerine

3.4 fluid onces (100 ml)

SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
WATER (UNII: 059QF0KO0R)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80535-0003-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/19/2020
Labeler - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
Registrant - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
Establishment
NameAddressID/FEIBusiness Operations
FARMACIA SAN ARCANGEL, S.A DE C.V951583068label(80535-0003) , manufacture(80535-0003) , pack(80535-0003)

Revised: 10/2020
Document Id: b20a7bd2-2b7b-7265-e053-2995a90ad7b5
Set id: b20a7bd2-2b7a-7265-e053-2995a90ad7b5
Version: 1
Effective Time: 20201019
 
FARMACIA SAN ARCANGEL, S.A DE C.V