Dr. Clean Antibacterial Hand Sanitizer by Sonchin Biomedical Cosmetics Corp. Sonchin 017-01

Dr. Clean Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Dr. Clean Antibacterial Hand Sanitizer 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 SANITIZER- benzalkonium chloride spray 
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 017-01

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

• Helps reduce bacteria on the skin
• Recommended for repeated use

Warnings

For external use only.

Do not use

• on children less than 2 months of age
• on open skin wounds
• around eyes
• in ears and mouth

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water

Stop use and ask a doctor

if irritation or rash occurs.

Keep out of reach of children.

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

Directions

• Pump as need into your palms and thoroughly spread on both hands. Rub hands together briskly until dry.

Other information

• Store between 20-25˚C (68-77˚F)

Inactive ingredients

Purified Water, Glycerine, Aloe Barbadensis Miller, Fragrance, Propylene Glycol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Polysorbate 20, Vitis Vinifera Fruit Extract, Hamamelis Extract

Package Label - Principal Display Panel

100 ml NDC: 73662-017-01

DR. CLEAN ANTIBACTERIAL HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73662-017
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
GLYCERIN (UNII: PDC6A3C0OX)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
ALOE (UNII: V5VD430YW9)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WINE GRAPE (UNII: 3GOV20705G)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73662-017-01	100 mL in 1 BOTTLE, SPRAY; 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(73662-017)

Revised: 6/2022

Document Id: e14f63e3-4f2c-5b39-e053-2995a90a0f5f

34390-5

Set id: b51154e9-b0a8-fd97-e053-2a95a90a40f1

Version: 2

Effective Time: 20220613