HAND SANITIZER- isopropyl 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

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77110-300
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)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77110-300-05	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
2	NDC: 77110-300-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
3	NDC: 77110-300-03	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
4	NDC: 77110-300-02	944 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
5	NDC: 77110-300-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	07/15/2020

Labeler - Biominerales Pharma, LLC (117489663)

Establishment
Name	Address	ID/FEI	Business Operations
Biominerales Pharma, LLC		117489663	MANUFACTURE(77110-300)