Vitastem

Vitastem
SPL v10
SPL
SPL Set ID a6630858-7038-425f-8a75-bb25f36a0dbe
Route
TOPICAL
Published
Effective Date 2019-03-27
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 Magnesium Stearate Methylparaben Sodium Hydroxide Sorbic Acid Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-11-08 Until 2024-12-09

Description

Tetracycline-HCI 30mg

Purpose

First Aid/Antibiotic


Medication Information

Purpose

First Aid/Antibiotic

Description

Tetracycline-HCI 30mg

Warnings:

For external use only. May be harmful is swallowed.

Do not use if allergic to any ingredient listed on this label. Allergy Alert:

Do Not Use
  • In eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
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.
  • 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.

Stop use if product is misused

Indications:

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

Active Ingredient

Tetracycline-HCI 30mg

Package Labeling:

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, Stearic 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.

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious trauma
Vitastem Tetracycline Hydrochloride Ointment, 100 Ml (71262 002 02

Vitastem Tetracycline Hydrochloride Ointment, 60 Ml (71262 002 01)


Structured Label Content

Purpose

First Aid/Antibiotic

Warnings:

For external use only. May be harmful is swallowed.

Do not use if allergic to any ingredient listed on this label. Allergy Alert:

Do Not Use (Do not use)
  • In eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor
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.
  • 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.

Stop use if product is misused

Indications:

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

Active Ingredient

Tetracycline-HCI 30mg

Package Labeling:

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, Stearic 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious trauma
Vitastem Tetracycline Hydrochloride Ointment, 100 Ml (71262 002 02 (VITASTEM-tetracycline hydrochloride ointment, 100 ml (71262-002-02)

Vitastem Tetracycline Hydrochloride Ointment, 60 Ml (71262 002 01) (VITASTEM-tetracycline hydrochloride ointment, 60 ml (71262-002-01))


Advanced Ingredient Data


Raw Label Data

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