Ohana Mahaalo Hand Gel HN

Ohana Mahaalo Hand Gel HN by

Drug Labeling and Warnings

Ohana Mahaalo Hand Gel HN by is a Otc medication manufactured, distributed, or labeled by Fragrancy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OHANA MAHAALO HAND GEL HN- ethyl alcohol gel 
Fragrancy Inc.

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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Ohana Mahaalo Hand Gel HN

Active Ingredient

Ethyl Alcohol 80 %

Purpose

Antiseptic

Warnings

Warnings

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

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.

Keep out of reach of children.

Directions

Wet hand thoroughly with product and allow to dry without wiping

Place enough product in the palm of your hands to thoroughly cover you hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Inactive Ingredients:

Inactive Ingredients

Inactive Ingredients:

water, glycerin, cabomer, PEG-60 hydrogenated castor oil, fragrance, tetrahydrooxypropyl ethylenediamine, 1,2-hexandiol, betaine, cyprylyl glycol, alpha-isomethyl ionone, butylene glycol, tocoperhol, methylpropanediol, camellia sinensis leaf extract, sodium hyaluronate, soluble collagen, ethylhexylglyerin, butylated hydroxytoulene

OHANA MAHAALO HAND GEL HN 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81074-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64 mL  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81074-0001-1	80 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/12/2020	06/23/2021

Labeler - Fragrancy Inc. (692637646)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrancy Inc.		692637646	manufacture(81074-0001)

Revised: 6/2021

Document Id: c57b71cd-1566-d9b8-e053-2a95a90a64b9

34390-5

Set id: b34ec508-cef0-740c-e053-2995a90ad2cb

Version: 2

Effective Time: 20210623