Hand Sanitizer Gel
FDA Label NDC 78697-128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nine Mile Health, Llc for the product Hand Sanitizer Gel (NDC 78697-128). 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

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Drug Facts

Manufactured by Economy Polymers and Chemicals
435 E Anderson Road, Houston, TX 77047

Distributed by Nine Mile Health, LLC
5500 Greenwood Plaza Blvd., Suite 130, Greenwood Village, CO 80111

Active Ingredient(S)

Alcohol 80% v/v

Purpose

Antiseptic

Use(S)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water 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
  • 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 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 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.

Other Information

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

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Questions?

www.ninemilehealth.com

Principal Display Panel - 3785 Ml Bottle Label

NINE MILE
HEALTH

GEL

ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION

1
GALLON
(3785 mL)
| NON-STERILE SOLUTION

Principal Display Panel (3785 mL Bottle Label)

Principal Display Panel (3785 mL Bottle Label)

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