Advanced Hand Sanitizer
FDA Label NDC 77110-100

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 Advanced Hand Sanitizer (NDC 77110-100). 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 (s), purpose, use(s), warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug facts

Active Ingredient (S)

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Use(S)

Hand Sanitizer to help reduce bacteria on the skin when water and soap are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • Children under 6 years of a age should be supervise when using this product
  • On open skin wounds

Otc - When Using

When using this product keep out 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 for more than 72 hours, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children. If swallowed, get medical help or contact a 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 or misuse.

Other Information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

glycerin, hydrogen, peroxide, purified water USP

Principal Display Panel - 3785 Ml Bottle Label

BIOMINERALES
PHARMA

ADVANCED
HAND SANITIZER

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.

Disposal:
Dispose of contents/ container to an approved waste disposal plant.

Active ingredients
Ethyl Alcohol 80%
Glycerin 1.45%
Hydrogen Peroxide .125%
Sterilized water 18.425%

Net Contents 3785 ML

Made in the USA

Principal Display Panel (3785 ML Bottle Label)

Principal Display Panel (3785 ML Bottle Label)

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