FDA.reportPublic FDA data

Tetracyte Topical Spray

Manufacturer
WOUNDS PROS, LLC
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:13

Label at a glance#

ProductTetracyte Topical
Active ingredientTETRACYCLINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Tetracycline-HCL 30mg

Purpose

OTC - PURPOSE SECTION

First Aid/Antibiotic

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. May be harmful if swallowed.

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

Do not use

OTC - DO NOT USE SECTION

  • in eyes 
  •  over large areas of the body 
  • longer than 1 week unless directed by doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious trauma

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2180656tetracycline HCl 3 % Topical SprayPSN3
2180656tetracycline hydrochloride 30 MG/ML Topical SpraySCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TETRACYCLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79790-001-002025-01-30C16284748780-12cef2736-70d8-d83d-e063-dadaa90ab31fTetracyte Topical Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79790-001-00Tetracyte Topical1 in 1 BOXSPRAY13
79790-001-00Tetracyte Topical55 mL in 1 BOTTLESPRAY553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79790-001TETRACYTE TOPICAL (TETRACYCLINE HYDROCHLORIDE) SPRAY [WOUNDS PROS, LLC]3Legacy NDC, 2 package rows20231202_f2bc68ac-5563-4ade-a75d-6517a7e97f72.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79790-00179790-001-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETIC ACIDQ40Q9N063PIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HISTIDINE4QD397987EIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
TETRACYCLINE HYDROCHLORIDEP6R62377KVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b6e2e9a-a928-0d1c-e063-6394a90aa411f2bc68ac-5563-4ade-a75d-6517a7e97f722023-12-01WarningsExact identifier
spl id: 0b6e2e9a-a928-0d1c-e063-6394a90aa411
spl set id: f2bc68ac-5563-4ade-a75d-6517a7e97f72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.