PROCLEAN HAND SANITIZER- isopropyl alcohol gel 
Biominerales Pharma

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.

----------

PROCLEAN HAND SANITIZER

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

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label
PROCLEAN HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-220-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
2NDC:77110-220-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
3NDC:77110-220-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E09/15/2020
Labeler - Biominerales Pharma (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma117489663MANUFACTURE(77110-220)

Revised: 9/2020
Document Id: ea8c5af5-1e14-4391-895e-33e1bbcdd5fa
Set id: f664dc9c-81a5-4d8f-af1d-f532ba81026b
Version: 1
Effective Time: 20200909
 
Biominerales Pharma