Antibacterial Foaming Hand Wash by Sonchin Biomedical Cosmetics CORP. Sonchin 011-01

Antibacterial Foaming Hand Wash by

Drug Labeling and Warnings

Antibacterial Foaming Hand Wash by is a Otc medication manufactured, distributed, or labeled by Sonchin Biomedical Cosmetics CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 011-01

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, Methylisothiazolinone, Benzisothiazolinone.

Package Label - Principal Display Panel

260 mL NDC: 73662-011-01

ANTIBACTERIAL FOAMING HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73662-011
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
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)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73662-011-01	260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/25/2020	12/31/2021

Labeler - Sonchin Biomedical Cosmetics CORP. (656155727)

Establishment
Name	Address	ID/FEI	Business Operations
Sonchin Biomedical Cosmetics CORP.		656155727	manufacture(73662-011)

Revised: 6/2022

Document Id: e14f4096-d45e-110e-e053-2a95a90a4f14

34390-5

Set id: b4e514f1-f1c4-552c-e053-2995a90ab2cb

Version: 2

Effective Time: 20220613