HYGEIA EFFECT HAND SANITIZER- alcohol 70% gel

Hygeia Effect Hand Sanitizer by

Drug Labeling and Warnings

Hygeia Effect Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pecan Bayou Enterprises, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Antiseptic, Hand Sanitizer

Use

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

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or 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 the eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

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

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

STOP USE

Stop use and ask a doctor is rash or irritation occurs. This may be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Place enough on hands to cover all surfaces. Rub hands until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-50C (59-86F)

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

Inactive Ingredients

Water, Glycerine USP, Carbomer, TEA

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

HYGEIA EFFECT HAND SANITIZER 
alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76605-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	662 mL  in 946 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	1 mL  in 946 mL
GLYCERIN (UNII: PDC6A3C0OX)	84 mL  in 946 mL
WATER (UNII: 059QF0KO0R)	199 mL  in 946 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76605-119-01	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2021

Labeler - Pecan Bayou Enterprises, LLC (117491868)

Registrant - Pecan Bayou Enterprises, LLC (117491868)

Establishment
Name	Address	ID/FEI	Business Operations
Pecan Bayou Enterprises, LLC		117491868	manufacture(76605-119)