HAND SANITIZER- isopropyl alcohol gel 
Biominerales Pharma, LLC

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.

----------

HAND SANITIZER

DRUG FACTS

Active ingredient

Isopropyl alcohol (70% v/v)

Purpose

Antiseptic

Inactive ingredients

Purified Water, Glycerin, Carbomer, Triethanolamine, Hydrogen Peroxide.

Use (s)

Hand sanitizer to help reduce 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 our 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.

Manufactured for and
Distributed by:
Biominerales Pharma, LLC
Boca Raton, Florida 33442

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

BIOMINERALES
PHARMA

Kills more than 99.99 % of germs

HAND SANITIZER

4 oz. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-300
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-300-05118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
2NDC:77110-300-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
3NDC:77110-300-03472 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
4NDC:77110-300-02944 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
5NDC:77110-300-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E07/15/2020
Labeler - Biominerales Pharma, LLC (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma, LLC117489663MANUFACTURE(77110-300)

Revised: 7/2020
Document Id: 1775d1fd-4922-496f-bcb6-13bff5c318d7
Set id: 9963c42c-2c6d-47e9-9149-bbd2b47b6f7d
Version: 1
Effective Time: 20200709
 
Biominerales Pharma, LLC