PURE GEL HAND SANITIZER- ethyl alcohol gel 
American Textile & Apparel Inc.

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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Pure Gel™ Hand Sanitizer Gel

Drug Facts

Active Ingredient

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 fire or flames

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 thoroughly with water

Stop use and ask a doctor if

• Irritation or redness develops. 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 59 – 86° F (15 -30°C)
• Avoid freezing and excessive heat above 104° F (40°C)

Inactive Ingredients

Purified water, glycerin, aculyn excel, triethanolamine.

Kills 99.9% of Germs

PureGel kills germs while keeping your hands soft and supple.

Fragrance Free

PRODUCT OF HONDURAS

Cleanliness is extremely important. Protect your loved ones by utilizing PureGel to kill germs and keep your hands soft and fresh.

Our formula has proven to be highly effective to kill germs and keep our hands clean, all while promoting soft and non sticky skin.

MaskD Health LLC, 10408 West State Road 84, Davie, FL 33324.

1-844-308-0458     WWW.SHOPMASKDHEALTH.COM

Packaging

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PURE GEL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79168-435
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACULYN EXCEL (POLYMER DISPERSION) (UNII: RD9Y6KOY5S)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79168-435-0259.15 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
2NDC:79168-435-04118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
3NDC:79168-435-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
4NDC:79168-435-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
5NDC:79168-435-413785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
6NDC:79168-435-4518925 mL in 1 PAIL; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/18/2020
Labeler - American Textile & Apparel Inc. (141249107)

Revised: 9/2020
Document Id: b1964630-68b1-4a41-ab6a-ed7f55d1f8b2
Set id: d3f80d9b-dc52-4043-a537-ab9b9665ac0f
Version: 2
Effective Time: 20200903
 
American Textile & Apparel Inc.