ACNECYCLINE - 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.     
 

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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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

  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.      
 

CHILDREN

 
Keep away from children.      

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.   

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


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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  Repeat the process three times daily.  For best results, refrigerate this product to reduce oxidation rate; to preserve effectiveness and color (normally orange).  Discard this product if color turns black.

USE


  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.      

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, sodium bicarbonate.

Image of product

Image of product

ACNECYCLINE 
tetracycline hydrochloride ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-116
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
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ascorbic acid (UNII: PQ6CK8PD0R)  
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)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43074-116-02 1 in 1 BOTTLE, PLASTIC
1 NDC:43074-116-01 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 02/15/2011
Labeler - Phillips Company (612368238)
Establishment
Name Address ID/FEI Business Operations
Phillips Company 612368238 manufacture

Revised: 2/2011
Document Id: 71e97088-421a-4286-a5de-3cd1561d8350
Set id: 3a5e4a8e-20bb-4bf8-8a2e-8dfd7f2afb49
Version: 1
Effective Time: 20110215
 
Phillips Company