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  5. Label Information: Aurora Fresh Gel 71

FDA Label for Aurora Fresh Gel 71

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT(S)
    3. PURPOSE
    4. USE(S)
    5. WARNINGS
    6. DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Aurora Fresh Gel 71 Product Label

The following document was submitted to the FDA by the labeler of this product Aurora Specialty Chemistries. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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