FIRST DEFENSE ATTACK BROAD-SPECTRUM HAND SANITIZER 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- isopropyl 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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FIRST DEFENSE ATTACK BROAD-SPECTRUM HAND SANITIZER WITH ALOE VERA

Active Ingredient(s)

Isopropyl Alcohol 70%

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame

Foe external use only

Use in or near the eyes. In case of cantact, rinse eyes thoroughly with water.

Irriation or rash appears and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a poison Control Center right away.

Keep out of reach of children

If swallowed, get medical help or contact a poison Control Center right away.

Directions

Put enough prodcut 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 110°F (43°F)

May discolor certain fabric surfaces.

Inactive ingredients

Water/aqua, Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Amidomethyl Propanol.

Package Label - Principal Display Panel

59 ml NDC: 61354-023-02

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-023
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
GLYCERIN (UNII: PDC6A3C0OX)	1.49 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26.98 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-023-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2021	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/19/2021	02/15/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-023)

Revised: 2/2023

Document Id: f45d92db-3df1-af4d-e053-2995a90a5cb4

34390-5

Set id: bbb2a2ad-2f8a-4a47-e053-2a95a90a1874

Version: 2

Effective Time: 20230210