My Shield Sanitizing Bath: Package Insert and Label Information

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.

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
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Label4
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MY SHIELD SANITIZING BATH
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71884-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
CAPRYLYL GLUCOSIDE
CITRIC ACID MONOHYDRATE
LAURETH-4
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71884-004-01 48 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/01/2018 12/31/2021
Labeler — ESC Brands LLC (202621850)
Establishment
Name Address ID/FEI Operations
Filltech USA, LLC 926433855 manufacture (71884-004)

Revised: 10/2021 ESC Brands LLC

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