DYABETEX- tetracycline hydrochloride ointment

Dyabetex by

Drug Labeling and Warnings

Dyabetex by is a Otc medication manufactured, distributed, or labeled by Phillips Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

DRUG FACTS
Active Ingredient                           Purpose
Tetracycline (3%) .......................  First-aid antibiotic

Uses  
First aid to help prevent skin infection in minor cuts, scrapes and burns
For external use only.      
Keep away from children.      
Do not use in the eyes or apply over large areas of the body.       
May be harmful if swallowed.       
In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
Stop use and consult a physician if the condition persists or gets worse.       Do not use if allergic to any ingredient listed on this label.     
Do not use longer than 1 week. 
Discard this product 1 week after opening bottle.     

Directions
Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.

Other information    
This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth.

Inactive ingredients   
Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.  

Side effects
Same as other tetracycline products.  
See listing of side effects online at
www.PhillipsCompany.4T.com/CC.pdf
Report any side effects to Phillips Company,
311 Chickasaw Street, Millerton, OK USA 74750  
Tel. 580-746-2430.
Email:  PhillipsCompany@cox.net

ACTIVE INGREDIENTS

Active Ingredient                           Purpose
Tetracycline (3%) .......................  First-aid antibiotic

ASK DOCTOR

ASK DOCTOR
   
  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
  Stop use and consult a physician if the condition persists or gets worse.

DO NOT USE

  For external use only.      
  Keep away from children.      
  Do not use in the eyes or apply over large areas of the body.       
  May be harmful if swallowed.       
  Do not use if allergic to any ingredient listed on this label.      
  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     

CHILDREN

 
Keep away from children.      
Discard this product 1 week after opening bottle.    

PURPOSE

Active Ingredient                           Purpose
Tetracycline (3%) .......................  First-aid antibiotic

STOP USE

Stop use and consult a physician if the condition persists or gets worse.       

Do not use if allergic to any ingredient listed on this label.   

Do not use longer than 1 week.  Discard this product 1 week after opening bottle.    

WHEN USING

  First aid to help prevent skin infection in minor cuts, scrapes and burns
  
  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
 

WARNINGS

Side effects:  same as other tetracycline products.  
See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf
Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750  
Tel. 580-746-2430.  Email:  PhillipsCompany@cox.net

DOSAGE & ADMINISTRATION

Directions
Clean the affected area.  Apply 2 drops of this liquid on the affected area about the size of a nickel or dime, and rub gently using a cotton swab.    For international users, a nickel or a dime is approximately 1.5 square centimeters.  Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.

USE

Uses  
  First aid to help prevent skin infection in minor cuts, scrapes and burns
  For external use only.      
  Keep away from children.      
  Do not use in the eyes or apply over large areas of the body.       
  May be harmful if swallowed.       
  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      
  Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.      
  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.

INACTIVE INGREDIENTS

Water, glycerin, hydroxethylcellulose, chlorhexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.

Image of product

Image of product

INGREDIENTS AND APPEARANCE

DYABETEX 
tetracycline hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43074-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)	TETRACYCLINE	0.03 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
dipropylene glycol (UNII: E107L85C40)
Water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
calcium gluconate (UNII: SQE6VB453K)
methylparaben (UNII: A2I8C7HI9T)
sodium hydroxide (UNII: 55X04QC32I)
sorbic acid (UNII: X045WJ989B)
magnesium stearate (UNII: 70097M6I30)
stearic acid (UNII: 4ELV7Z65AP)
CHOLECALCIFEROL (UNII: 1C6V77QF41)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43074-108-02	1 in 1 BOTTLE, PLASTIC
1	NDC: 43074-108-01	3 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/24/2010

Labeler - Phillips Company (612368238)

Establishment
Name	Address	ID/FEI	Business Operations
Phillips Company		612368238	manufacture