MEDI DEFENSE MPULSE HAND SANITIZER- benzalkonium chloride spray
CLEARSTREAM TECHNOLOGIES, LLC

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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Medi Defense mPulse Hand Sanitizer

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Help reduce bacteria on the skin.

Recommended for repeated use

Warnings

For external use only.

Avoid contact with eyes. In case of eye contact flush thoroughly with water.

Keep out of reach of children.

Directions

Apply product to hands and rub until dry.

Storage

Store in cool dry place between 35 0 and 103 0F

Inactive ingredients

Deionized Water, Propylene glycol, Triethylene glycol, PEG-75 Lanolin complex, Organo Silane Quaternaries

Product label

image description

MEDI DEFENSE MPULSE HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73795-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73795-001-01	59.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020
2	NDC:73795-001-02	236.58 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020
3	NDC:73795-001-03	3785.41 mL in 1 DRUM; Type 0: Not a Combination Product	03/21/2020
4	NDC:73795-001-04	18927.1 mL in 1 DRUM; Type 0: Not a Combination Product	03/21/2020
5	NDC:73795-001-05	208198 mL in 1 DRUM; Type 0: Not a Combination Product	03/21/2020
6	NDC:73795-001-06	1040987.75 mL in 1 JUG; Type 0: Not a Combination Product	03/21/2020
7	NDC:73795-001-07	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/21/2020

Labeler - CLEARSTREAM TECHNOLOGIES, LLC (116962029)

Name	Address	ID/FEI	Business Operations
Establishment
TOLL SOLUTIONS LLC		004854914	manufacture(73795-001)

Name	Address	ID/FEI	Business Operations
Establishment
RWM Technologies LLC		626626969	manufacture(73795-001)