Frist Defense Attack Broad-Speactrum Hand Sanitizer with Aloe Vera

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- isopropyl alcohol liquid 
Lexia, 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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Frist Defense Attack Broad-Speactrum Hand Sanitizer with Aloe Vera

Active Ingredient(s)

Isopropyl Alcohol 70 % v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

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, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethyl Propanol.

Package Label - Principal Display Panel

59 ml NDC: 70179-030-01

148ml NDC: 70179-030-02

236mL NDC: 70179-030-03

473mL NDC: 70179-030-04

HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70179-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70.929 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)	26.989 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70179-030-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2020	02/10/2023
2	NDC: 70179-030-02	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2020	02/10/2023
3	NDC: 70179-030-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2020	02/10/2023
4	NDC: 70179-030-04	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2020	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/13/2020	02/15/2023

Labeler - Lexia, LLC (015552120)

Establishment
Name	Address	ID/FEI	Business Operations
OXYGEN DEVELOPMENT		137098492	manufacture(70179-030)

Revised: 2/2023

Document Id: f45dafaf-70b3-27b1-e053-2995a90ac467

34390-5

Set id: acc8ec51-8193-de65-e053-2995a90a9bf5

Version: 3

Effective Time: 20230210

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