PROCLEAN HAND SANITIZER- isopropyl alcohol gel

PROCLEAN HAND SANITIZER by

Drug Labeling and Warnings

PROCLEAN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Biominerales Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Isopropyl Achohol 70%

Purpose

Antiseptic

Inactive ingredients

Water (aqua), carbomer, glycerin, propylene glycol, hydrogen peroxide, aminomethyl propanol

Use(s)

Hand sanitizer to help reduce the bacteria that potentially can cause disease. For use when water and soap are not available

Warnings

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

Do not use in children less than 2 months of age or 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 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

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

PROCLEAN

HAND SANITIZER GEL

This product should be used as part
of the daily hand cleansing routine

70% ISOPROPYL ALCOHOL
Fights germs and bacteria

1 GAL (3.79 L)

MADE IN CANADA
NDC#77110-220-01

INGREDIENTS AND APPEARANCE

PROCLEAN HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77110-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77110-220-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020
2	NDC: 77110-220-02	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020
3	NDC: 77110-220-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	09/15/2020

Labeler - Biominerales Pharma (117489663)

Establishment
Name	Address	ID/FEI	Business Operations
Biominerales Pharma		117489663	MANUFACTURE(77110-220)