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

Warnings

  • 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

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 Single Label

MEDAMA FOAM HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81776-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81776-204-011000 mL in 1 CONTAINER; Type 0: Not a Combination Product04/13/202107/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/13/202107/31/2024
Labeler - Ace Janitorial Supply co., Inc. (080453756)

Revised: 9/2022
Document Id: e99ad2dd-3e07-a18f-e053-2995a90a70e2
Set id: bfdb27c8-de55-eccc-e053-2995a90ad04f
Version: 2
Effective Time: 20220926
 
Ace Janitorial Supply co., Inc.