Goodwill Labs Advanced Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
Oxygen Development LLC

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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Goodwill Labs Advanced Hand Sanitizer

Active Ingredients

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from sources of heat, fire or flame.
For external use only.

Warnings

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

Stop use and ask a doctor if irritation or redness develops and lasts.

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Place enough product in your palm to thoroughly cover your hands
Rub hands together until dry
Recommended for repeated use
Children under 6 years should be supervised when using this product

Other information

Store at a temperature below 110F (43C)
May discolor certain fabrics or surfaces

Inactive ingredients

Water, Aminomethyl Propanol, Carbomer, Methyl Gluceth-20

Package Label - Principal Display Panel

473 mL NDC: 61354-022-01

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	0.9 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	35.97 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.05 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-022-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2021	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/18/2021	02/15/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-022)

Revised: 2/2023

Document Id: f45d92db-3df2-af4d-e053-2995a90a5cb4

34390-5

Set id: bba19d60-5752-4cad-e053-2995a90ad554

Version: 2

Effective Time: 20230210