MY-SHIELD SANITIZING- benzalkonium chloride liquid
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 Soap

Drug Facts

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic Hand Soap

Uses

• Handwash to help reduce bacteria that potentially can cause disease • Helps to prevent crosscontamination by hand contact • Helps to prevent drying of skin • Recommended for repeat use

Warnings

For external use only.

When using this product

do not use in or near eyes.

Stop use and ask doctor if

irritation and redness develop.

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions

• Wet Hands and wrists with clean running water • Apply appropriate amount of product • Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly • Rinse thoroughly with running water • Dry hands completely (incomplete drying may result in chapped skin)

Other Information

Store in a cool dry place below 104° F (40°C)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aqua, Benzyl Alcohol, Citric Acid, Glycerin, Hydrolysed Silk, Lauramidopropyl Betaine, Phenoxyethanol.

Questions?

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

Package Labeling:

Label Label2

MY-SHIELD SANITIZING
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71884-003
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 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71884-003-08	250 mL in 1 BOTTLE; 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(71884-003)

Revised: 10/2021

Document Id: cdc551cf-977e-0f18-e053-2a95a90aeb0b

Set id: 8858dcba-92d5-4895-ac07-dd73185d1094

Version: 4

Effective Time: 20211007

ESC Brands LLC