Dr. Clean Antibacterial Hand Sanitizer by Sonchin Biomedical Cosmetics Corp. Sonchin 014-01

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- alcohol gel 
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 014-01

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antibacterial

Use

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

Warnings

For external use only.

Flammable. Keep away from fire or flame.

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

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

• avoid contact with broken skin
• do not inhale or ingest

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Purified Water, Glycerine, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Sucrose Octaacetate, Tert-Butyl Alcohol

Package Label - Principal Display Panel

300 ml NDC: 73662-014-01

DR. CLEAN ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73662-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
WATER (UNII: 059QF0KO0R)
SUCROSE OCTAACETATE (UNII: 07V591057T)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73662-014-01	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(73662-014)

Revised: 6/2022

Document Id: e14f5e54-dc6e-5756-e053-2a95a90a205b

34390-5

Set id: b50f3423-aced-53c8-e053-2995a90ab87c

Version: 2

Effective Time: 20220613