FDA.reportPublic FDA data

Diabecline

Manufacturer
Phillips Company
Effective date
2013-07-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 22:36:03

Label at a glance#

ProductDiabecline
Active ingredientTETRACYCLINE HYDROCHLORIDE
Label structure12 sections

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

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION


Tetracycline hydrochloride 30 mg

Purpose

OTC - PURPOSE SECTION

Purpose
First Aid Antibiotic

use

INDICATIONS & USAGE SECTION

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



Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION


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

OTC - ASK DOCTOR SECTION

 deep or puncture wounds
 animal bites
 serious burns

Stop use and ask a doctor

OTC - STOP USE SECTION



  if condition persists or gets worse.

Keep Out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiabeclineTopicalOintmentLabel
DiabeclineTopicalOintmentLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542815Diabecline 3 % Topical OintmentPSN9
1542813tetracycline HCl 3 % Topical OintmentPSN9
1542815tetracycline hydrochloride 0.03 MG/MG Topical Ointment [Diabecline]SBD9
1542813tetracycline hydrochloride 0.03 MG/MG Topical OintmentSCD9
1542815Diabecline 0.03 MG/MG Topical OintmentSY9
1542815Diabecline 3 % Topical OintmentSY9
1542813tetracycline HCl 3 % Topical OintmentSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TETRACYCLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1284307411211Diabecline_Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43074-112-112020-01-31C16284748780-19d75b9d0-c20b-f424-e053-dadaa90a57ceDiabecline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43074-112-11Diabecline3 g in 1 BOTTLEOINTMENT39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43074-112DIABECLINE (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]9Legacy NDC, 1 package rows20130712_3d858754-b3d0-49cb-834e-9b9a35eea0fa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KV9
TETRACYCLINEACTIVE MOIETYF8VB5M810T9
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R9
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E9
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF419
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H9
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C409
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT9
GLYCERININACTIVE INGREDIENTPDC6A3C0OX9
HYDROXYMETHYL CELLULOSEINACTIVE INGREDIENT273FM27VK19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I309
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I9
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP9
WATERINACTIVE INGREDIENT059QF0KO0R9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43074-11243074-112-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRACYCLINE HYDROCHLORIDEP6R62377KVACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 453 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f934f64d-4fc0-4344-85fa-51312257a5913d858754-b3d0-49cb-834e-9b9a35eea0fa2013-07-12WarningsExact identifier
spl id: f934f64d-4fc0-4344-85fa-51312257a591
spl set id: 3d858754-b3d0-49cb-834e-9b9a35eea0fa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.