Maxim Instant Foam Hand Sanitizer by Midlab, Inc.

Maxim Instant Foam Hand Sanitizer by

Drug Labeling and Warnings

Maxim Instant Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Midlab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAXIM INSTANT FOAM HAND SANITIZER- benzalkonium chloride liquid 
Midlab, 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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Active Ingredient

Benzalkonium Chloride

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry

Inactive Ingredients

Water, cocamidopropyl PG-dimonium chloride phosphate, dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid

Package Label

MAXIM INSTANT FOAM HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-250
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)

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: 70542-250-41	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2021
2	NDC: 70542-250-55	208198 mL in 1 DRUM; Type 0: Not a Combination Product	10/21/2021
3	NDC: 70542-250-32	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/21/2021	06/27/2022

Labeler - Midlab, Inc. (047371463)

Registrant - Midlab, Inc. (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
Midlab, Inc.		047371463	manufacture(70542-250)

Revised: 8/2022

Document Id: e5fd1225-0fa7-a874-e053-2a95a90a9f62

34390-5

Set id: cb03703e-853e-2912-e053-2a95a90a1474

Version: 2

Effective Time: 20220811

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