ANTIBACTERIAL FOAMING HAND WASH- benzalkonium chloride soap
Sonchin Biomedical Cosmetics CORP.

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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Sonchin 021-01

Active Ingredient(s)

Benzalkonium Chloride (0.13%)

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only.

Wehn using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

Irritation or redness develops.

Keep out of reach of children.

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

Directions

Pump into wet hands.
Lather vigorously for at least 20 seconds.
Rinse & dry thoroughly.
Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Purified Water, Cocamidopropyl Betaine, Cocamide DEA, Decyl Glucoside, Glycerin, Lauryl/Myristyl Amidopropyl Amine Oxide, Polysorbate 20, Aloe Barbadensis Leaf Juice, Fragrance, Tetrasodium EDTA, Citric Acid,Methylchloroisothiazolinone, Methylisothiazolinone.

Package Label - Principal Display Panel

021-01 260 mL NDC: 73662-021-01

ANTIBACTERIAL FOAMING HAND WASH
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73662-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAUROYL/MYRISTOYL AMIDOPROPYL AMINE OXIDE (UNII: HY9O6ZW9CY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73662-021-01	260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/14/2021	12/31/2021

Labeler - Sonchin Biomedical Cosmetics CORP. (656155727)

Name	Address	ID/FEI	Business Operations
Establishment
Sonchin Biomedical Cosmetics CORP.		656155727	manufacture(73662-021)

Revised: 6/2022

Document Id: e14f380e-95a0-9161-e053-2a95a90a8a3a

Set id: c2317625-370b-50f8-e053-2995a90a6eed

Version: 2

Effective Time: 20220613

Sonchin Biomedical Cosmetics CORP.