Tetrastem
FDA Label NDC 43074-301

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 Tetrastem (NDC 43074-301). 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 drug facts, 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.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Gram)

Tetracycline hydrochloride 30 mg

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

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

Package Label

TetraStem
brand


Refrigerate
Topical
Ointment


First Aid
Antibiotic
Tetracycline
Hydrochloride


NET WT. 0.1 OZ (3 G)

Patent Pending                           NDC 43074-301-11
Alcohol free, no biological products
www.PhillipsCompany.4T.com
Phillips Company       Take it to the people
Millerton, OK 74750 USA


Remove top of plastic box to read full contents of the
enclosed Drug Facts label. Plastic box top is not sealed.

Side effects
Same as other tetracycline products
See listing of side effects online at
www.PhillipsCompany.4T.com/CC.pdf
Report any side effects to Phillips Company,
311 Chickasaw Street, Millerton, OK 74750 USA
Tel. 580-746-2430
Email: [email protected] TetraStem

Front (Front)

Front (Front)

Back (Bottle)

Back (Bottle)

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