Paramount Hand Sanitizer Gel

Paramount Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

PARAMOUNT HAND SANITIZER- alcohol gel 
Paramount Enterprise, 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.

----------

Paramount Hand Sanitizer Gel

Drug Facts

Active ingredient

Alcohol 80%

Purpose

Antiseptic

Uses

• for hand sanitizing to decrease bacteria on the skin.
• recommended for repeated use.

Warnings
For external use only.

Flammable. Keep away from fire and flame.

When using this product keep away from eyes. In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develop or persist for more than 72 hours.

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

Directions

• Wet hands thoroughly with product
• Rub hands together until dry.
• Supervise children under 6 years old
• Not recommended for infants

Other information

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

Inactive ingredients

Glycerin, Vitamin E, Hydrogen peroxide, Purified water, Carbopol

Distributed by
Paramount Enterprises
18566 Office Park Drive,

Montgomery Village MD 20886, USA

(240)-364-4401
www.paramountenter.com
Made in Pakistan

Ethaol 80%

Paramount

HAND SANITIZER

Helps prevent bacterial infections

Alcohol 80%

ANTISEPTIC FORMULA GEL

236 ML (8 FL OZ)

PARAMOUNT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79788-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79788-002-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	11/15/2021
2	NDC: 79788-002-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	11/15/2021
3	NDC: 79788-002-05	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	11/15/2021
4	NDC: 79788-002-06	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	11/15/2021
5	NDC: 79788-002-07	296 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	11/15/2021
6	NDC: 79788-002-09	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	11/15/2021
7	NDC: 79788-002-11	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	11/15/2021
8	NDC: 79788-002-12	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	11/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/30/2020	11/15/2021

Labeler - Paramount Enterprise, LLC (117589412)

Revised: 11/2021

Document Id: d0dae396-9019-1e64-e053-2995a90a3e6c

34390-5

Set id: abc3104f-0350-2c8b-e053-2995a90a2724

Version: 4

Effective Time: 20211115