Healthy Hands Plus by Maintex Healthy Hands Plus

Healthy Hands Plus by

Drug Labeling and Warnings

Healthy Hands Plus by is a Otc medication manufactured, distributed, or labeled by Maintex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY HANDS PLUS- ethyl alcohol liquid 
Maintex

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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Healthy Hands Plus

ACTIVE INGREDIENT

Ethyl Alcohol ...........70.0% v/v

Inactive Ingredients 

Acrylates/Perfluorohexylethyl Methacrylate Copolymer, Glycerin, Isopropyl Alcohol, Perfluorohexylethyl Alcohol, Water

Purpose

Antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin.

recommended for repeated use.

Warnings

For external use only.

When Using this Product

- Avoid contact with eyes.

- In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

-Irritation or redness develops, if condition persists for more than 72 hours. 

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Directions

-Pump a small amount of foam into palm of hand.  

-Rub thoroughly over all surfaces of both hands.  

-Rub hands together brisky until dry

-Use between hand washings to help reduce germ tranmission 

Healthy Hands Plus

Healthy Hands Plus

HEALTHY HANDS PLUS 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-015-01	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/29/2020
2	NDC: 77617-015-02	1 L in 1 BOX; Type 0: Not a Combination Product	12/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/29/2020	01/18/2022

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Maintex		008317307	manufacture(77617-015) , api manufacture(77617-015) , pack(77617-015)

Revised: 1/2022

Document Id: e9842f3d-d6f7-46f5-9ad8-4f687927defc

34390-5

Set id: a0636b48-7002-4502-9e3f-6a973b9d9d2b

Version: 5

Effective Time: 20220118