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)

Alcohol 70% . Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from heat or flame. For external use only.

When using this product do not use in or near the eyes. In case of contact, 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 palm 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

473 mL NDC: 63154-011-05

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: 61354-011-05	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/24/2020	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: f45da1c6-af15-e9d1-e053-2995a90adc78

34390-5

Set id: ad436556-2415-44a8-e053-2995a90a0afe

Version: 2

Effective Time: 20230210