Hand Sanitizer
FDA Label NDC 77110-270

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biominerales Pharma, Llc for the product Hand Sanitizer (NDC 77110-270). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, inactive ingredients, use (s), warnings, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

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

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.

Otc - Do Not Use

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

Otc - When Using

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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.

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)

Principal Display Panel (3,785 mL Bottle Label)

Principal Display Panel (3,785 mL Bottle Label)

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