HAND SANITIZER- alcohol gel 
EXPORTADORA IN & OUT S DE RL DE CV

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

Ethyl alcohol v/v - 70%

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 from fire and flame

When using this product

keep out of eyes, 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 eyes, 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 contro 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 105F (40C)

-May discolour certain fabrics

-Harmful to wood finishes and plastics

Inactive ingredients

Purified water (aqua), vegetable glycerin and carboxymethyl cellulose and hydrocypropyl methylcellulose (HPMC)

Question or comments

call: (956) 999-5319

visit www.phiimportingcompany.com

PRINCIPAL DISPLAY

LABEL 250 ML HAND SANITIZER

KILLS 99.9% OF MOST GERMS

70% ALCOHOL VOLUME

NON STERILE SOLUTION

8.5 FL OZ (250 ML )

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD) 0.1 mL  in 100 mL
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77210-0008-1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - EXPORTADORA IN & OUT S DE RL DE CV (951577298)

Revised: 6/2020
Document Id: a7c110a7-c3da-e3f8-e053-2995a90a4043
Set id: a7c110a7-c3d9-e3f8-e053-2995a90a4043
Version: 1
Effective Time: 20200610
 
EXPORTADORA IN & OUT S DE RL DE CV