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

Isopropyl Alcohol 70% Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from sources of heat, fire 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 immediately.

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 fabrics surfaces

Inactive ingredients

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

Package Label - Principal Display Panel

473 ml NDC: 61354-023-04

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: 61354-023-04	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(61354-023)

Revised: 2/2023

Document Id: f45d96fc-44d2-8dc7-e053-2995a90a2386

34390-5

Set id: bbb1f297-1535-9550-e053-2995a90a0d41

Version: 2

Effective Time: 20230210