Oxygen Health & Wellness Hand Sanitizer Soothing Gel Infused with Aloe Vera

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- alcohol liquid 
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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Oxygen Health & Wellness Hand Sanitizer Soothing Gel Infused with Aloe Vera

Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame. For extenal use only.

When using this product do not use in or neear the 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 appears and lasts.

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

Directions

• Put enough product in your palms to cover hands and rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F (43C)
• May discolor certain fabric surfaces.

Inactive ingredients

water, glycerin, carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice.

Package Label - Principal Display Panel

2 mL NDC: 61354-011-04

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.473 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.496 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27.445 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-011-04	2 mL in 1 CELLO PACK; Type 0: Not a Combination Product	06/09/2020	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020	02/15/2023

Labeler - OXYGEN DEVELOPMENT LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
OXYGEN DEVELOPMENT LLC		137098492	manufacture(61354-011)

Revised: 2/2023

Document Id: f45d92db-3df3-af4d-e053-2995a90a5cb4

34390-5

Set id: a7a948c5-3551-b5c7-e053-2995a90a2f33

Version: 3

Effective Time: 20230210