AURORA FRESH GEL 71- alcohol gel 
Aurora Specialty Chemistries

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aurora Fresh Gel 71 Gel Hand Sanitizer with Vitamin E 8.4 oz (250 mL) Container

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

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.

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.

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

8.4 oz (250 mL) NDC: 77807-005-02image descriptionimage description

AURORA FRESH GEL 71 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77807-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 27.77 L  in 1 L
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) 0.7 L  in 1 L
GLYCERIN (UNII: PDC6A3C0OX) 1.39 L  in 1 L
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.07 L  in 1 L
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.07 L  in 1 L
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77807-005-020.25 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/24/2021
Labeler - Aurora Specialty Chemistries (108423153)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Specialty Chemistries117783355manufacture(77807-005)

Revised: 3/2021
Document Id: c8800fe0-1768-4af3-b4a1-3a3163b57ed7
Set id: d03ea19c-2285-4a4f-a249-c3d1ce6ebfe2
Version: 1
Effective Time: 20210324
 
Aurora Specialty Chemistries