HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77110-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77110-200-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 77110-200-02	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 77110-200-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 77110-200-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 77110-200-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - Biominerales Pharma, LLC (117489663)

Establishment
Name	Address	ID/FEI	Business Operations
Biominerales Pharma, LLC		117489663	MANUFACTURE(77110-200)