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 70% v/v

Purpose

Antiseptic

Inactive ingredients

Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate, Purified Water, Fragrance.

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 - 3,785 mL Bottle Label

BIOMINERALES
PHARMA

HAND SANITIZER - GEL

Kills more than 99.99% of germs

Prevention:
Keep away from heat / sparks / open flames / hot surfaces.
No Smoking. Keep container tightly closed.
Response:
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice / attention. In case of fire:
Use dry sand, dry chemical or alcohol - resistant foam for extinction.
Storage:
Store in a well-ventilated place. Keep cool. Store Between
15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above
40 °C (104 °F)
Disposal:
Dispose of contents / container to an approved waste disposal plant.

Active Ingredients: Ethyl Alcohol 70% v/v

NDC: 77110-270-01

Manufactured for and
Distributed by:
Biominerales Pharma, LLC
Boca Raton, Florida 33442
www.biomineralespharma.com

Net Contents
1 Gal. (3,785 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77110-270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77110-270-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
2	NDC: 77110-270-06	944 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
3	NDC: 77110-270-02	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
4	NDC: 77110-270-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
5	NDC: 77110-270-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
6	NDC: 77110-270-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	06/15/2020

Labeler - Biominerales Pharma, LLC (117489663)

Establishment
Name	Address	ID/FEI	Business Operations
Biominerales Pharma, LLC		117489663	MANUFACTURE(77110-270)