PRO CLEAN INSTANT HAND SANITIZER- alcohol liquid

Pro Clean Instant Hand Sanitizer by

Drug Labeling and Warnings

Pro Clean Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sistemas de Sanitazion y Fragancias Avanzados S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]

Ethyl Alcohol 70%

Purpose

Antiseptic

Use[s]

To help reduce bacteria and germs on the skin that potentially can cuase disease. Recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from heat or flame

Do not use

• in eyes, in case of contact rinse eyes thoroughly with water
• 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 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 20-25C (68-77F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, carbomer, triethanolamine, glycerin.

Package Labeling:29ml

Package Labeling:59ml

Package Labeling:236ml

Package Labeling:295ml

Package Labeling:473ml

Package Labeling:3785ml

INGREDIENTS AND APPEARANCE

PRO CLEAN INSTANT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80570-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80570-001-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
2	NDC: 80570-001-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
3	NDC: 80570-001-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
4	NDC: 80570-001-04	295 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
5	NDC: 80570-001-05	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
6	NDC: 80570-001-06	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2020

Labeler - Sistemas de Sanitazion y Fragancias Avanzados S.A. (817612362)

Establishment
Name	Address	ID/FEI	Business Operations
Sistemas de Sanitazion y Fragancias Avanzados S.A.		817612362	manufacture(80570-001)