Tetracyte Topical Ointment Tetracycline Hydrochloride

Tetracyte Topical Ointment Tetracycline Hydrochloride
SPL v3
SPL
SPL Set ID 4ac5177d-bb67-45e6-adcf-44f0821746bd
Route
TOPICAL
Published
Effective Date 2024-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracycline (30 mg)
Inactive Ingredients
Acetic Acid Ascorbic Acid Chlorhexidine Gluconate Cholecalciferol Dimethyl Sulfoxide Dipropylene Glycol Gluconolactone Glycerin Histidine Hydroxyethyl Cellulose, Unspecified Magnesium Stearate Methylparaben Sodium Hydroxide Sorbic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Tetracycline-HCl 30mg 

Purpose

First Aid/Antibiotic


Medication Information

Purpose

First Aid/Antibiotic

Description

Tetracycline-HCl 30mg 

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert

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 1 to 3 times daily
  • may be covered with a sterile bandage

Stop use if product is misused

  • this product is an OTC antibiotic for human use
  • contains no alcohol, no animal ingredients
  • blended for typical skin color
  • may stain cloth
  • no clamis regarding stem cell healing are implied for this product
Do Not Use
  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
Drug Facts

Indications

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

Other Information
  • Keep refrigerated
Package Labelling:

Inactive Ingredients

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, water

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.

Active Ingredient (in Each Gram)

Tetracycline-HCl 30mg 

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious trauma

Structured Label Content

Purpose

First Aid/Antibiotic

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert

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 1 to 3 times daily
  • may be covered with a sterile bandage

Stop use if product is misused

  • this product is an OTC antibiotic for human use
  • contains no alcohol, no animal ingredients
  • blended for typical skin color
  • may stain cloth
  • no clamis regarding stem cell healing are implied for this product
Do Not Use (Do not use)
  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
Drug Facts

Indications

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

Other Information
  • Keep refrigerated
Package Labelling:

Inactive Ingredients

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition persists or gets worse.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Tetracycline-HCl 30mg 

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious trauma

Advanced Ingredient Data


Raw Label Data

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