SERENE CLEAN AND PURE ANTIBACTERIAL HAND- benzakonium chloride liquid 
Serene Clean & Pure 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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Serene Clean & Pure Antibacterial Hand Soap

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For handwashing to help reduce bacteria on the skin

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor

if irritation or redness develops and condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Inactive ingredients

Water, EDTA, Glycerin, Sodium Dodecylbenzenesulfonate, Coco-betaine, Sodium Laureth Sulfate, Phenoxyethanol

Package Label - Principal Display Panel

Serene Clean & Pure

Kills 99.99% of Germs & Bacteria

Benzalkonium Chloride

Antibacterial Hand Soap

16 fl oz

www.serenepure.com

ABOUT

Serene Clean & Pure is a family owned company that believes in honest and helpful products.

Serene Clean & Pure hand soap is an antibacterial hand soap that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

Distributed by:

Serene Clean & Pure

555 Anton Blvd. Suite 105

Costa Mesa, CA 92626

Label

SERENE CLEAN AND PURE ANTIBACTERIAL HAND 
benzakonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78643-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78643-200-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/09/2020
Labeler - Serene Clean & Pure LLC (117539963)
Registrant - Serene Clean & Pure LLC (117539963)
Establishment
NameAddressID/FEIBusiness Operations
Morgan Gallacher Inc.028311595manufacture(78643-200)

Revised: 7/2020
Document Id: aa0f9ffe-4bae-6799-e053-2995a90abf14
Set id: aa0f9ffe-4bad-6799-e053-2995a90abf14
Version: 1
Effective Time: 20200709
 
Serene Clean & Pure LLC