Label: VK (cypress oil, eucalyptus oil, coral calcium- ct-ccp40 liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77083-201-01, 77083-201-02 - Packager: CaltecBio Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated April 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Acive Ingredient[s]
- Purpose
- Use[s]
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
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[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
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INGREDIENTS AND APPEARANCE
VK
cypress oil, eucalyptus oil, coral calcium (ct-ccp40) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77083-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM HYDROXIDE (UNII: PF5DZW74VN) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN) CALCIUM HYDROXIDE 0.0053 g in 100 mL 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 98.7947 mL in 100 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.6 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77083-201-01 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/10/2020 2 NDC:77083-201-02 300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/10/2020 Labeler - CaltecBio Co., Ltd (695625851) Registrant - CaltecBio Co., Ltd (695625851) Establishment Name Address ID/FEI Business Operations CaltecBio Co., Ltd 695625851 manufacture(77083-201)