Medama Foam Hand Sanitizer

Medama Foam Hand Sanitizer by

Drug Labeling and Warnings

Medama Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ace Janitorial Supply co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDAMA FOAM HAND SANITIZER- ethanol liquid 
Ace Janitorial Supply co., 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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Medama Foam Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
• Recommended for repeated use.

Warnings

• For external use only.

• Keep out of eyes, ears, or mouth.

• Discontinue use if irritation occurs.

• Keep out of reach of children.

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Directions

• If hands are visibly soiled, wash with soap and water and dry hands.
• Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive ingredients

benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

Medama Solutions

1365 62st Street, Brooklyn, New York, 11219

P 718.492.7200 F 718.492.3878

MADE IN THE USA

MEDAMA

Waterless Foam Hand Sanitizer

1000 ml

MEDAMA FOAM HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81776-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81776-204-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/13/2021	07/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/13/2021	07/31/2024

Labeler - Ace Janitorial Supply co., Inc. (080453756)

Revised: 9/2022

Document Id: e99ad2dd-3e07-a18f-e053-2995a90a70e2

34390-5

Set id: bfdb27c8-de55-eccc-e053-2995a90ad04f

Version: 2

Effective Time: 20220926