X-PROUSA ANTISEPTIC HAND SANITIZER GEL, CLEAN AND FRESH SCENT- alcohol gel

X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent by

Drug Labeling and Warnings

X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent by is a Otc medication manufactured, distributed, or labeled by X-PROUSA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 72%

Purpose

Antiseptic

Use

• Hand sanitizer to help reduce bacteria on the skin that could cause disease.
• Recommended for repeated use 

Warnings

• For external use only.
• Flammable. Keep away from heat or flame

Do not use

• Do not use on children less than 2 months of age.
• Do not use 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 rash occurs. 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 15-30°C (59-86°F) 
Avoid freezing and excessive heat above 40°C (104°F )

Inactive ingredients

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Tocopherol Acetate, Fragrance(s)

Package Labeling:30ml

Package Labeling:60ml

Package Labeling:118ml

Package Labeling:240ml

Package Labeling:470ml

Package Labeling:950ml

Package Labeling:3800ml

INGREDIENTS AND APPEARANCE

X-PROUSA ANTISEPTIC HAND SANITIZER GEL, CLEAN AND FRESH SCENT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79490-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79490-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
2	NDC: 79490-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
3	NDC: 79490-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
4	NDC: 79490-001-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
5	NDC: 79490-001-16	470 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
6	NDC: 79490-001-32	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020
7	NDC: 79490-001-38	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/21/2020

Labeler - X-PROUSA LLC (117567866)