Diabecline
FDA Label NDC 43074-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Phillips Company for the product Diabecline (NDC 43074-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding diabecline brand topical ointment first aid antibiotic tetracycline hydrochloride 0.1 oz (3 g), active ingredient (in each gram), purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

* Please review the disclaimer below.