Oomph Antiseptic Instant Hand Sanitizer

Oomph Antiseptic Instant Hand Sanitizer by

Drug Labeling and Warnings

Oomph Antiseptic Instant Hand Sanitizer 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- alcohol liquid 
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.

----------

Oomph Antiseptic Instant Hand Sanitizer

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.

Inactive ingredients

Denatonium benzoate, glycerin, hydrogen peroxide, water.

Questions or Comments:

657-529-1111

Package Labeling:

OOMPH ANTISEPTIC INSTANT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79319-001
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
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79319-001-03	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/29/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/29/2020	12/31/2021

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

Revised: 10/2021

Document Id: ceb57eb4-4eca-0d90-e053-2995a90a1c0a

34390-5

Set id: ae7cafde-23f1-3813-e053-2a95a90ad5a3

Version: 2

Effective Time: 20211019