AURORA FRESH GEL- alcohol gel

Aurora Fresh Gel by

Drug Labeling and Warnings

Aurora Fresh Gel by is a Otc medication manufactured, distributed, or labeled by Aurora Specialty Chemistries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• In children less than 2 months of age
• On open skin wounds

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.

STOP USE

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

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: 77807-003-05

INGREDIENTS AND APPEARANCE

AURORA FRESH GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77807-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77807-003-05	18927 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Aurora Specialty Chemistries (108423153)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Specialty Chemistries		108423153	manufacture(77807-003)