Dr. Clean Antibacterial Hand Wash by Sonchin Biomedical Cosmetics CORP. Sonchin 018-01

Dr. Clean Antibacterial Hand Wash by

Drug Labeling and Warnings

Dr. Clean Antibacterial 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]

DR. CLEAN ANTIBACTERIAL 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 018-01

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

Avoid contact with eyes. Of 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

• Wash hands and rinse.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 20-25˚C (68-77˚F)

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

300 mL NDC: 73662-018-01

DR. CLEAN ANTIBACTERIAL HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73662-018
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 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)
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: 73662-018-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/27/2020	12/31/2021

Labeler - Sonchin Biomedical Cosmetics CORP. (656155727)

Establishment
Name	Address	ID/FEI	Business Operations
Sonchin Biomedical Cosmetics CORP.		656155727	manufacture(73662-018)

Revised: 6/2022

Document Id: e14f63e3-4f2b-5b39-e053-2995a90a0f5f

34390-5

Set id: b512a84c-846d-1e67-e053-2a95a90a55c4

Version: 2

Effective Time: 20220613