DIABECLINE- 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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Diabecline

Diabecline Brand Topical Ointment First Aid Antibiotic Tetracycline Hydrochloride 0.1 OZ (3 G)

Active Ingredient (in each gram)


Tetracycline hydrochloride 30 mg

Purpose

Purpose
First Aid Antibiotic

use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.



Warnings

For external use only. May be harmful if swallowed.
Allergy alert: Do not use if allergic to any ingredient listed on this label.


Do Not Use


in the eyes.
over large areas of the body.
longer than 1 week unless directed by doctor.

Ask a doctor before use if you have

 deep or puncture wounds
 animal bites
 serious burns

Stop use and ask a doctor



  if condition persists or gets worse.

Keep Out of reach of children

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

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 1 to 3 times daily. May be covered with a sterile bandage.

Other Information


Keep product refrigerated to preserve its effectiveness and color.
Stop use if product is misused: If the bottle is left open and/or if not refrigerated, the liquid will tend to turn black over time.
Discard the product if the liquid turns black due to misuse.
This product is an OTC antibiotic for human use.
Contains no alcohol, no animal ingredients.
Blended for typical skin color.
May stain cloth.
No claims regarding stem cell healing are implied for this product.

INACTIVE INGREDIENTS

ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL,
DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA
LACTONE, GLYCERIN, HYDROXETHYLCELLULOSE, MAGNESIUM
STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID,
STEARIC ACID, WATER

Diabecline Brand Topical Ointment First Aid Antibiotic Tetracycline Hydrochloride 0.1 OZ (3 G)

DiabeclineTopicalOintmentLabel
DIABECLINE 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-112-113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/10/2013
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture(43074-112)

Revised: 7/2013
Document Id: f934f64d-4fc0-4344-85fa-51312257a591
Set id: 3d858754-b3d0-49cb-834e-9b9a35eea0fa
Version: 9
Effective Time: 20130712
 
Phillips Company