Vi. Clean by GDP International Co., Ltd / CaltecBio Co., Ltd 79549-201

Drug Details [pdf]

VI. CLEAN- cypress oil, eucalyptus oil, coral calcium (ct-ccp50) liquid
GDP International Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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79549-201

Active Ingredient[s]

Cypress oil 0.5%

Eucalyptus oil 0.1%

Coral calcium (CT-CCP50) 0.0053%

Purpose

Disinfection

Use[s]

Disinfection and odor elimination of indoor spaces and objects.

Warnings

For external use only.

Do not use

for the purpose other than described above.

When using this product

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

Stop use and ask a doctor

if appears any allergic symptom.

Keep out of reach of children.

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

Directions

Shake the product well and spray at 30~40 cm distance from the place where needs disinfection or elimination of odor.

Other Information

- Store at room temperature

- Avoid freezing and excessive heat above 40C

Inactive Ingredient

polysorbate 80, water

[Precautions]

[General matter] Check the indications before use. Follow the indicated method of use and standard amount to spray. Do not let the contents come into contact with your eyes.

[Exposure on human body] Do not inhale or drink.

[Purpose of use] Do not use other than the purpose of the product indicated in the label. Do not arbitrarily change the container.

[Leakage of content] If the container is fallen down, the liquid may leak. Do not neglect it and do not give impact such as dropping.

[Storage] Keep away from ﬁre or heat. Store in a cool place away from direct sunlight, and keep the lid closed after use.

[Emergency measure] If you are exposed to the product and feel uncomfortable, seek help from a medical institution (doctor). If you inhale it and feel diﬃculty in breathing, move to a place where you can get fresh air and rest with a breathable position.

[Others] White stains may appear after the solution dries. The white stain is a calcium carbonate produced by the natural reaction of coral calcium solution with oxygen, so it is not defect or pigment in the product.

Package Label

60ml NDC: <a href=/NDC/79549-201-01>79549-201-01</a> Label

300ml NDC: <a href=/NDC/79549-201-02>79549-201-02</a> Label

VI. CLEAN
cypress oil, eucalyptus oil, coral calcium (ct-ccp50) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79549-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.1 g in 100 mL
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O) (CUPRESSUS SEMPERVIRENS LEAF OIL - UNII:M7QUY89S4O)	CUPRESSUS SEMPERVIRENS LEAF OIL	0.5 g in 100 mL
CALCIUM HYDROXIDE (UNII: PF5DZW74VN) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN)	CALCIUM HYDROXIDE	0.0053 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79549-201-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/13/2020	11/30/2020
2	NDC: 79549-201-02	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/13/2020	11/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/13/2020	11/30/2020

Labeler - GDP International Co., Ltd (695641153)

Registrant - GDP International Co., Ltd (695641153)

Name	Address	ID/FEI	Business Operations
Establishment
CaltecBio Co., Ltd		695625851	manufacture(79549-201)

Revised: 11/2020

Document Id: b54fac34-9a3b-77a9-e053-2a95a90a936c

Set id: aa4ac3ce-d5d6-7a5d-e053-2995a90a6814

Version: 2

Effective Time: 20201130