FDA.reportPublic FDA data

VetraSeb CeraDerm

Manufacturer
MWI/VETONE | Ceva Sante Animale
Effective date
2021-04-20
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:57

Label at a glance#

ProductVetraSeb CeraDerm P MOUSSE
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure6 sections

Storage and handling

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

VetraSeb™ CeraDerm™ P

Soothing Anti-itch Leave-on Mousse for Dogs or Cats

CUCUMBER MELON

For veterinary use only

ACTIVE INGREDIENTS: Pramoxine HCl 1%.

INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Avena Sativa (Oat) Kernel Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: A leave-on mousse with pramoxine to help relieve itching. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

INDICATIONS & USAGE SECTION

INDICATIONS: For use on dogs or cats for the temporary relief of itching and skin irritations.

DIRECTIONS FOR USE: Shake well before use.  Brush the fur then apply product. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.

For localized application:​ Dispense 1 to 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the haircoat again.

For whole body application:  Dispense 1 or 2 pumps onto your palm and massage on the skin and hair. Massage into the skin until fully penetrated. Repeat as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the haircoat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs. For deeper cleansing, use VetraSeb™ CeraDerm™ P Conditioning Shampoo.

WARNINGS AND PRECAUTIONS SECTION

CAUTIONS: For external use on dogs or cats only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

WARNING: Keep out of reach of children.

STORAGE AND HANDLING SECTION

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by: MWI

Boise, Idaho 83705

www.VetOne.net

QUESTIONS? 1-800-999-0297

PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VETone®

VetraSeb™ CeraDerm™ P

Mousse

Pramoxine HCl 1%

Soothing Anti-itch Leave-on Mousse for Dogs or Cats

CUCUMBER MELON

For veterinary use only

Net Contents: 6.8 FL. OZ. (200 mL)

200 mL bottle label200 mL bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2539965pramoxine hydrochloride 1 % Topical FoamPSN1
2539965pramoxine hydrochloride 10 MG/ML Topical FoamSCD1
2539965pramoxine hydrochloride 1 % Topical FoamSY1
2539965pramoxine hydrochloride 1 % Topical MousseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-439-68VetraSeb CeraDermP MOUSSE200 mL in 1 BOTTLE, PLASTICLIQUID2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-439VETRASEB CERADERM P MOUSSE (PRAMOXINE HYDROCHLORIDE) LIQUID [MWI/VETONE]11 package rows20210424_246e1e36-0a78-4f0b-a809-400aea79cc21.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-43913985-439-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYSORBATE 806OZP39ZG8HIACT
POLOXAMER 184BIS92ZSF57IACT
ALOE VERA LEAFZY81Z83H0XIACT
AVENANTHRAMIDES5PA41O4AITIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE EOSCR0J8RN66KIACT
CERAMIDE NP4370DF050BIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
PROCTOFOAM NSPRAMOXINE HYDROCHLORIDEViatris Specialty LLCcddc8d81-21b8-11e4-8c21-0800200c9a662025-08-15WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
DerMend Moisturizing Anti-ItchPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.14c7fb1c-a310-4b12-ab2e-7f1c0801995c2024-12-17WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Anti Itch Soothing 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC8bfeea34-25d5-4721-a17f-d9f1d0084cc32024-08-01WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE
First Degree Maximum Strength BurnPRAMOXINE HYDROCHLORIDEWelmedix LLC1afa337e-f411-42df-b2f5-5f72c9b52ffa2017-03-09WarningsName fallback
generic name: PRAMOXINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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