Oomph Antiseptic Instant Hand Sanitizer Gel

Oomph Antiseptic Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

Oomph Antiseptic Instant Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Pascoe's Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OOMPH ANTISEPTIC INSTANT HAND SANITIZER GEL- alcohol gel 
Pascoe's Pty. Ltd.

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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Oomph Antiseptic Instant Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

• for hand washing to decrease bacteria on the skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

• Store below 86°F (30°C)

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, denatonium benzoate, glycerin, hydrogen peroxide, triethanolamine, water.

Package Labeling: 2.3ml

Package Labeling: 50ml

Package Labeling: 250ml

Package Labeling: 450ml

Package Labeling: 500ml

Package Labeling: 1L

Package Labeling: 5L

OOMPH ANTISEPTIC INSTANT HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79319-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79319-000-00	2.3 mL in 1 PACKET; Type 0: Not a Combination Product	07/15/2020	12/31/2021
2	NDC: 79319-000-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/15/2020	12/31/2021
3	NDC: 79319-000-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020	12/01/2022
4	NDC: 79319-000-15	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020	12/31/2021
5	NDC: 79319-000-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020	12/01/2022
6	NDC: 79319-000-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020	12/31/2021
7	NDC: 79319-000-66	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/15/2020	12/01/2022

Labeler - Pascoe's Pty. Ltd. (757898978)

Revised: 10/2021

Document Id: ceb59225-d095-296b-e053-2995a90a541c

34390-5

Set id: ae7d0854-c8aa-1db3-e053-2995a90a47b7

Version: 2

Effective Time: 20211019