AURORA FRESH GEL- 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 Lime Citrus Scented Hand Sanitizer with Vitamin E 5 Gallons (18.9 L) Container

This is a gel hand sanitizer with citrus fragrance 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).
Carbomer-980 (0.7% v/v).
Isopropyl Myristate (0.07% v/v)
DL-Alpha-Tocopherol Acetate (0.07% v/v)
Trolamine (0.7% v/v)
Citral (0.07% v/v)
Sterile distilled water.

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 be signs 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, trolamine, carbomer, tocopheryl acetate, isopropyl myristate, fragrance

Package Label - Principal Display Panel

5 GAL (18.9 L) NDC: 77807-003-05image description

AURORA FRESH GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77807-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 27 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.39 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.07 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.07 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.7 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP) 0.07 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77807-003-0518927 mL in 1 CONTAINER; Type 0: Not a Combination Product08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2020
Labeler - Aurora Specialty Chemistries (108423153)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Specialty Chemistries108423153manufacture(77807-003)

Revised: 1/2022
Document Id: 4849298a-32c9-4794-91b3-22b38856cca1
Set id: a48d1905-94b6-45b1-a0e0-ca96e5a84adc
Version: 5
Effective Time: 20220124
 
Aurora Specialty Chemistries