MedShield Products by HWL Holdings, LLC / MEDIPROMTECH, LLC HWL- Distributor Liquid

MedShield Products by

Drug Labeling and Warnings

MedShield Products by is a Otc medication manufactured, distributed, or labeled by HWL Holdings, LLC, MEDIPROMTECH, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDSHIELD PRODUCTS- hand sanitizer liquid 
HWL Holdings, 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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HWL- Distributor Liquid

Active Ingredient(s)

Benzalkonium Chloride 0.1% Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that could cause disease

Warnings

For external use only-hands

keep out of eyes In case of contact with eyes, rinse eyes thoroughly with water.

if skin irritation develops.

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

Directions

• Rub thoroughly over all the surfaces of both hands.
• Rub hands together briskly until dry.

Inactive ingredients

glycerol, purified water USP

Package Label - Principal Display Panel

100 mL NDC: 75446-123-02

MEDSHIELD PRODUCTS 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75446-123
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75446-123-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020
2	NDC: 75446-123-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020	12/20/2023

Labeler - HWL Holdings, LLC (058630887)

Establishment
Name	Address	ID/FEI	Business Operations
MEDIPROMTECH, LLC		520862497	manufacture(75446-123)

Revised: 12/2022

Document Id: efd5031f-5d87-c259-e053-2a95a90aedc1

34390-5

Set id: af5f7288-49d7-0c7f-e053-2995a90a829d

Version: 3

Effective Time: 20221214