FDA.reportPublic FDA data

TetraStem - Topical Ointment

Manufacturer
Phillips Company
Effective date
2014-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:29

Label at a glance#

ProductTetraStem
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 hydrochloride 30 mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Other information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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: hp@valliant.net TetraStem

frontfront

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542813tetracycline HCl 3 % Topical OintmentPSN1
1542813tetracycline hydrochloride 0.03 MG/MG Topical OintmentSCD1
1542813tetracycline HCl 3 % Topical OintmentSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130004307301112GTIN-13: 0004307301112
EAN-13: 0004307301112
GTIN-12: 004307301112
UPC-A: 004307301112
GTIN storage (14 digits): 00004307301112		bottle.jpg

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
43074-301-112020-01-31C16284748780-19d75b9d0-4a65-f424-e053-dadaa90a57ceTetraStem - Topical Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43074-301-11TetraStem3 g in 1 BOTTLEOINTMENT31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43074-301TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]1Legacy NDC, 1 package rows20140225_1c6c18db-5e42-4942-a611-00d49651a91f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KV1
TETRACYCLINEACTIVE MOIETYF8VB5M810T1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063P1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HISTIDINEINACTIVE INGREDIENT4QD397987E1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
43074-30143074-301-11

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
TETRACYCLINE HYDROCHLORIDEP6R62377KVACTIB
ACETIC ACIDQ40Q9N063PIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HISTIDINE4QD397987EIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 502 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / TOPICALADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HIMPLANT / SUBCUTANEOUS104 mgExact identifier — unii candidate
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / SUBCUTANEOUS0.04 %w/vExact identifier — unii candidate
45 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PTABLET / ORALNAExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / INFILTRATIONNAExact identifier — unii candidate
45 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates

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
e739bfd8-0b05-48b3-859e-e6400d67b7211c6c18db-5e42-4942-a611-00d49651a91f2014-02-25WarningsExact identifier
spl id: e739bfd8-0b05-48b3-859e-e6400d67b721
spl set id: 1c6c18db-5e42-4942-a611-00d49651a91f

Reported adverse events (FAERS/openFDA)#

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