MY SHIELD SANITIZING BATH- benzalkonium chloride swab
ESC Brands 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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My-Shield Sanitizing Bath Wipe

Drug Facts

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic/Body Wash & Sanitizer

Uses:

Sanitizing bath wipes to clean, deodorize & decrease bacteria from the entire body - Recommended for single use.

Warnings:

Do not freeze. For external use only.

Do not use

in ears, eyes or mouth.

When using this product,

avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

• Be careful not to over heat
• Children should be supervised when using this product.

Directions:

Microwave for 30 seconds on medium, remove from packaging while warm, commence to wipe over the skin and wash the body to remove grime, odors and bacteria, dispose of used wipe in an approved manner.

Inactive Ingredients:

1-Octadecanaminium NN dimethyl (3-trimethoxysilyl) propyl chloride, -Octadecanaminium NN dimethyl (3-trihydroxysilyl) propyl chloride, Aloe Barbadenis leaf extract, Aqua, Caprylyl Glucoside, Citric Acid, Laureth-4, Methyl Parabens, Polyaminopropyl biguanide, Silk Protein.

Questions?

+1 (336) 655 2219, Mon-Fri 9:00AM-5:00PM (EST)

Package Labeling:

Label3 Label4

MY SHIELD SANITIZING BATH
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71884-004
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 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURETH-4 (UNII: 6HQ855798J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71884-004-01	48 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2018	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/01/2018	12/31/2021

Labeler - ESC Brands LLC (202621850)

Name	Address	ID/FEI	Business Operations
Establishment
Filltech USA, LLC		926433855	manufacture(71884-004)

Revised: 10/2021

Document Id: cdc4e8e4-b6d7-395a-e053-2995a90a7fbd

Set id: 4c20af86-8642-434b-8407-ccd61632cfe4

Version: 6

Effective Time: 20211007

ESC Brands LLC