PARAGON TM Sanitizing Hand Gel

Paragon Sanitizing Hand Gel 75% by

Drug Labeling and Warnings

Paragon Sanitizing Hand Gel 75% by is a Otc medication manufactured, distributed, or labeled by Transtar Autobody Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PARAGON SANITIZING HAND GEL 75%- isopropyl alcohol gel 
Transtar Autobody Technologies 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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PARAGONTM Sanitizing Hand Gel

Drug Facts

Active Ingredients:

Isopropyl alcohol 75% v/v

Purpose:

Antiseptic

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings:

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

Do not use on children less than 2 months of age on open skin wounds

When using this product keep out of 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 occurs. These may be signs of a serious condition.

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

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information:

Store between 59-86°F (15-30°C)
Avoid freezing and excessive heat above 104°F (40°C).

Inactive Ingredients:

Glycerin, hydrogen peroxide, hydroxypropyl cellulose, purified water USP.

Isopropyl Alcohol

Antiseptic 75%

Topical Solution 

Non-sterile Solution

Read cautions on the back panel.

TRANSTAR AUTOBODY TECHNOLOGIES, INC.

2040 Heiserman Dr. Brighton, MI 48114

www.tat-co.com Questions? (800) 824-2843

MADE IN THE USA

Packaging

PARAGON SANITIZING HAND GEL 75% 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79399-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 L  in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.087 L  in 100 L
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)	0.423 L  in 100 L
WATER (UNII: 059QF0KO0R)	23.04 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79399-101-03	0.1 L in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2020	08/20/2022
2	NDC: 79399-101-02	0.059 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
3	NDC: 79399-101-04	0.118 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
4	NDC: 79399-101-08	0.2365 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
5	NDC: 79399-101-16	0.473 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
6	NDC: 79399-101-64	1.89 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
7	NDC: 79399-101-63	1.89 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
8	NDC: 79399-101-32	0.946 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
9	NDC: 79399-101-71	3.78 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
10	NDC: 79399-101-72	3.78 L in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020	08/20/2022
11	NDC: 79399-101-81	18.9 L in 1 PAIL; Type 0: Not a Combination Product	07/24/2020	08/20/2022
12	NDC: 79399-101-82	18.9 L in 1 PAIL; Type 0: Not a Combination Product	07/24/2020	08/20/2022
13	NDC: 79399-101-55	208 L in 1 DRUM; Type 0: Not a Combination Product	07/24/2020	08/20/2022
14	NDC: 79399-101-75	1041 L in 1 CONTAINER; Type 0: Not a Combination Product	07/24/2020	08/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2020	08/20/2022

Labeler - Transtar Autobody Technologies LLC (061855185)

Establishment
Name	Address	ID/FEI	Business Operations
Transtar Autobody Technologies LLC		061855185	manufacture(79399-101)

Revised: 8/2022

Document Id: 7fae574c-e2aa-4872-a614-16653757014c

34390-5

Set id: c31b36a8-1a24-4439-ad81-f02798762e15

Version: 4

Effective Time: 20220822