Aurora Fresh Gel 71
FDA Label NDC 77807-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurora Specialty Chemistries for the product Aurora Fresh Gel 71 (NDC 77807-005). 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

This is a gel hand sanitizer manufactured according to standard cGMP.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with existing hand sanitizer products sold OTC throughout the United States and Globally:

Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (1.39% v/v).
Hydroxymethyl Cellulose (0.7% v/v).
Isopropyl Myristate (0.07% v/v)
DL-Alpha-Tocopherol Acetate (0.07% v/v)
Sterile distilled water (27.77% v/v).

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Isopropyl Alcohol 70% 

Purpose

Antiseptic / Hand Sanitizer

Use(S)

Hand Sanitizer to help reduce bacteria that potentially cause disease.
For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from 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 eyes thoroughly with water.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may besigns 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

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

deionized water, glycerin, hydroxypropyl cellulose, tocopheryl acetate, isopropyl myristate

Package Label - Principal Display Panel

16 oz (473 mL) NDC: 77807-005-10

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