OTC Medication Information: TETRACYTE TOPICAL – Tetracycline Hydrochloride

TETRACYTE TOPICAL — TETRACYCLINE HYDROCHLORIDE- tetracycline hydrochloride spray
THE WOUND DOCS, LLC

Drug Facts

Active Ingredient (in each gram)

Tetracycline-HCl 30mg

Purpose

First Aid/Antibiotic

Indications

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or 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 eyes • over large areas of the day

• longer than 1 week unless directed by doctor

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serous trauma

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

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 claims regarding stem cell healing are implied for this product

Other Information

• For best results refrigerate or store in a cool dark place.

Inactive Ingredinets

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, propanediol, glucono delta lactone, glycerin, histidine, hydroxyethyl cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling: TETRACYTE TOPICAL — tetracycline hydrochloride ointment, 55ml (82776-001-55)

Label2
(click image for full-size original)

TETRACYTE TOPICAL — TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82776-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
ASCORBIC ACID
CHLORHEXIDINE GLUCONATE
CHOLECALCIFEROL
DIMETHYL SULFOXIDE
PROPANEDIOL
GLUCONOLACTONE
GLYCERIN
HISTIDINE
HYDROXYETHYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
SODIUM HYDROXIDE
SORBIC ACID
STEARIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82776-001-55 1 BOTTLE in 1 BOX contains a BOTTLE
1 55 mL in 1 BOTTLE This package is contained within the BOX (82776-001-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M004 06/01/2022
Labeler — THE WOUND DOCS, LLC (118705435)

Revised: 12/2023 THE WOUND DOCS, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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