Hand Sanitizer
FDA Label NDC 79703-080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ginesis Natural Products for the product Hand Sanitizer (NDC 79703-080). 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, uses, 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

DIST. BY CJH
2501 COUNTY RD 8
WATERLOO, AL 35677

Active Ingredient

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

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 fire or flames.

Do Not Use

  • on children less than 2 months of age
  • on open skin wounds

Otc - When Using

When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.

Otc - Stop Use

Stop use and ask doctor if redness or irritation develop. 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 15-30° C (59-86°F)
  • Avoid freezing and excessive heat above 40° (104°F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Principal Display Panel - 59 Ml Bottle Label

GINESIS

Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer
Non-Sterile Solution

2 FL OZ. (59 ML)

Principal Display Panel (59 ML Bottle Label)

Principal Display Panel (59 ML Bottle Label)

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