OTC Medication Information: DSC Antibacterial Hand COCONUT LEMONGRASS

DSC ANTIBACTERIAL HAND COCONUT LEMONGRASS- benzalkonium chloride soap
Crystalline Heath & Beauty From The DEad Sea LTD

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

Antibacterial

Use

Helps eliminate bacteria on hands.

Warnings

For external use only.

When using this product

Avoid contact with eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor

if irritaion or redness persists.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use whenever washing your hands. Rinse with warm water.

Inactive ingredients:

Water/Aqua, Sodium Laureth Sulphate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Maris Sal (Dead Sea Minerals), Fragrance (Parfum), Cocos Nucifera (Coconut) Oil, Cymbopogon Schoenanthus Extract (Lemongrass), DMDM Hydantoin, Triethylene Glycol, Propylene Glycol, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Nitrate, Magnesium Chloride, Tetrasodium EDTA, Citric Acid.

Package Labeling:

DSC ANTIBACTERIAL HAND COCONUT LEMONGRASS benzalkonium chloride soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71095-006 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 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM CHLORIDE COCAMIDOPROPYL BETAINE GLYCERIN COCONUT OIL CYMBOPOGON SCHOENANTHUS TOP DMDM HYDANTOIN TRIETHYLENE GLYCOL PROPYLENE GLYCOL BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE MAGNESIUM NITRATE MAGNESIUM CHLORIDE EDETATE SODIUM CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71095-006-00 500 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 12/31/2022

Labeler — Crystalline Heath & Beauty From The DEad Sea LTD (600582704)

Establishment
Name	Address	ID/FEI	Operations
Crystalline Heath & Beauty From The DEad Sea LTD		600582704	manufacture (71095-006)

Revised: 06/2022 Crystalline Heath & Beauty From The DEad Sea LTD