DYABETEX - tetracycline hydrochloride ointment 
Phillips Company

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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DRUG FACTS

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.

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DYABETEX 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE0.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-108-021 in 1 BOTTLE, PLASTIC
1NDC:43074-108-013 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/24/2010
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture

Revised: 9/2010
Document Id: 683dc33c-ba75-4a12-acb1-e82d0ea98d78
Set id: 2c2b4ce1-2a54-4ff4-a660-14629a3df69f
Version: 1
Effective Time: 20100905
 
Phillips Company