PURE GEL HAND SANITIZER- ethyl alcohol gel

Pure Gel Hand Sanitizer by

Drug Labeling and Warnings

Pure Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by American Textile & Apparel Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PURE GEL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79168-435
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)
GLYCERIN (UNII: PDC6A3C0OX)
ACULYN EXCEL (POLYMER DISPERSION) (UNII: RD9Y6KOY5S)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79168-435-02	59.15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
2	NDC: 79168-435-04	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
3	NDC: 79168-435-08	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
4	NDC: 79168-435-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
5	NDC: 79168-435-41	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020
6	NDC: 79168-435-45	18925 mL in 1 PAIL; Type 0: Not a Combination Product	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/18/2020

Labeler - American Textile & Apparel Inc. (141249107)