CLEAN CONCEPT LAVENDER CALM ANTIBACTERIAL FOAMING HAND- benzalkonium chloride liquid
Economy Polymers and Chemicals

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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Clean Concept Lavender Calm Antibacterial Foaming Hand Soap

DRUG FACTS

ACTIVE INGREDIENT(S)

Benzalkonium Chloride 0.12%

PURPOSE

Antibacterial Hand Cleaner

USE(S)

For hand washing to decrease bacteria on the skin

WARNINGS

For external use only

Do Not Use

• In eyes or mouth

When using this product

• Keep out of eyes and mouth. If contact with eyes, rinse eyes promptly and thoroughly with water
• Discontinue if redness or irritation develops

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

DIRECTIONS

• Wet hands and desired area
• Apply product to adequately cover the surface
• Scrub thoroughly for atleast 30 seconds
• Rinse

OTHER INFORMATION

• Store between (15-20C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water (Aqua), glycerin, cocamidopropyl hydroxysultaine and cocamide, cocamidpropyl PGDimonium chloride phosphate, fragrance, benzl alcohol, citric acid

Package Labeling:

Label2

CLEAN CONCEPT LAVENDER CALM ANTIBACTERIAL FOAMING HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74830-544
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
COCAMIDE (UNII: 3YXD33R71G)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74830-544-01	547 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/31/2020

Labeler - Economy Polymers and Chemicals (008087603)