TETRACYTE TOPICAL - tetracycline hydrochloride ointment

TETRACYTE TOPICAL - tetracycline hydrochloride by

Drug Labeling and Warnings

TETRACYTE TOPICAL - tetracycline hydrochloride by is a Otc medication manufactured, distributed, or labeled by THE WOUND DOCS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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TETRACYTE TOPICAL - tetracycline hydrochloride ointment

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)

TETRACYTE TOPICAL - TETRACYCLINE HYDROCHLORIDE 
tetracycline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82776-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)	TETRACYCLINE HYDROCHLORIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
PROPANEDIOL (UNII: 5965N8W85T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HISTIDINE (UNII: 4QD397987E)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82776-001-55	1 in 1 BOX	06/01/2022	01/27/2025
1		55 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	06/01/2022	01/27/2025

Labeler - THE WOUND DOCS, LLC (118705435)

Revised: 1/2025

Document Id: 2cd8d6a1-4dee-e16b-e063-6294a90a1b76

34390-5

Set id: e1f1b5a7-970a-3639-e053-2995a90af4c0

Version: 3

Effective Time: 20250129