HAND SANITIZER- 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.

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HAND SANITIZER

DRUG FACTS

Active ingredient

Ethyl alcohol (80% v/v)

Purpose

Antimicrobial

Inactive ingredients

Water(18.025%v/v),Hydrogen Peroxide(0.125%v/v), Carbopol 940 (0.400% v/v), Glycerol (1.450% v/v).

Use (s)

Hand sanitizer to help reduce bacteria on the skin when water and soap are not available.

Warnings

Flammable. Keep away from heat or flame.

For External use only. When using this product keep our of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water for several minutes. Stop use and ask a doctor if irritation or rash occurs for more than 72 hours, consult a doctor.

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.

Lot : 001 | Exp. : 05 / 2020 | NDC: 77110-200-03

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

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

BIOMINERALES
PHARMA

Kills more than 99.99% of germs

HAND SANITIZER - GEL

8 oz. (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R) 18.025 mL  in 100 mL
Hydrogen Peroxide (UNII: BBX060AN9V) 0.125 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:77110-200-02472 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:77110-200-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
4NDC:77110-200-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
5NDC:77110-200-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Biominerales Pharma, LLC (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma, LLC117489663MANUFACTURE(77110-200)

Revised: 5/2020
Document Id: b1c9ba46-b51a-4b41-9868-df0e98be9a23
Set id: 98e973f8-6d70-4556-983c-64d25372bc6b
Version: 1
Effective Time: 20200527
 
Biominerales Pharma, LLC