Hand Sanitizer

Hand Sanitizer
SPL v1
SPL
SPL Set ID 5f1b4fa7-4854-4545-bf6c-1826d2af10b2
Route
TOPICAL
Published
Effective Date 2020-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol Aminomethylpropanol Isopropyl Myristate .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-15

Description

DRUG FACTS

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep our of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do not use in children less than 2 months of age or on open skin wounds.

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.

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.
Active Ingredient

Ethyl alcohol 70% v/v

Inactive Ingredients

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

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)


Structured Label Content

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep our of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use in children less than 2 months of age or on open skin wounds.

Purpose

Antiseptic

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.

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.
Active Ingredient (Active ingredient)

Ethyl alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 3,785 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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