Drug Labeling and Warnings

Drug Details [pdf]

ENVIRO MASTER FOAMING INSTANT HAND SANITIZER- benzalkonium chloride soap 
Midlab Incorporated

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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Principal Label

OTC Active Ingredient Section

OTC Purpose Section

Indications and Usage

Warnings Section

Ask Doctor Section

KOOROC

Dosage and Admin

Inactive Ingredients

ENVIRO MASTER FOAMING INSTANT HAND SANITIZER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
WATER (UNII: 059QF0KO0R)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Product Characteristics
Color	white (Water White/Clear Colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70542-502-41	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2018	04/29/2019

Labeler - Midlab Incorporated (047371463)

Registrant - Midlab Incorporated (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
Midlab Incorporated		047371463	manufacture(70542-502)

Revised: 4/2019

Document Id: 87af0f63-61dc-0d10-e053-2995a90a03c6

34390-5

Set id: 6c3f30f9-cf4f-069c-e053-2991aa0a1c99

Version: 2

Effective Time: 20190429