MEDAMA WATERLESS FOAM HAND SANITIZER- hand sanitizer liquid

Medama Waterless Foam hand Sanitizer by

Drug Labeling and Warnings

Medama Waterless Foam hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingedient

Ethyl Alcohol

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 AWA FROM FIRE OR FLAME.

When using

• Keep out of eyes, ears, or mouth.

Stoppage

• Discontinue use if irritation occurs.

Children

• Keep out of reach of children.

Directions

• If hands are visibly soiled, was 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 Single Label

MEDAMA

Waterless Foam Hand Sanitizer

Drug Facts

Active Ingredient                                             Purpose

Ethyl Alcohol 70% v/v……………………………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 AWA FROM FIRE OR FLAME.

Directions

• If hands are visibly soiled, was 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.

1000 ml

TMS68                                                                                  Medama Solutions

MADE                                                                                   1365 61st Street, Brooklyn, New York 11219

IN THE USA                                                                         P 718.492.7200 F 718.492.3878

5068-medama                   Rev. 1.0

Medama Hand Sanitizer Case label

TMS68                  5068-MEDAMA-CS          Rev. 1.0

MEDAMA

Waterless Fam hand Sanitizer

6 X 1000 ml                         Medama Solutions

MADE USA                          1365 61st Street, Brooklyn, New York 11219

IN THE                                P 718.492.7200 F 718.492.3878

INGREDIENTS AND APPEARANCE

MEDAMA WATERLESS FOAM HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 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)
PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATE (UNII: S4S9783N13)
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: 58575-204-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-204-02	6000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-204)