My-Shield Sanitizing Bath Wipe

My-Shield Sanitizing Bath Wipe

Drug Labeling and Warnings

Drug Details

k">

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.

----------

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:

Label3Label4

MY SHIELD SANITIZING BATH 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71884-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LAURETH-4 (UNII: 6HQ855798J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71884-004-0148 g in 1 PACKET; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2018
Labeler - ESC Brands LLC (202621850)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(71884-004)

Revised: 1/2019
 
ESC Brands LLC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.