FDA.reportPublic FDA data

VetraSeb CeraDerm

Manufacturer
MWI/VETONE | Ceva Sante Animale
Effective date
2021-04-06
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:55

Label at a glance#

ProductVetraSeb CeraDerm P
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure7 sections

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

VetraSeb™ CeraDerm™ P

Conditioning Shampoo

Pramoxine HCl 1%

Soothing Ant-itch Conditioning Shampoo for Dogs or Cats

CUCUMBER MELON

ACTIVE INGREDIENTS: Pramoxine HCI 1%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, PEG-7 Glyceryl Cocoate, Sodium Chloride, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Avena Sativa (Oat) Kernal Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Carthamus Tinctorius (Safflower) Seed Oil, PEG-8, Laurate, Laureth-4, Fragrance, Citric Acid, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES: A conditioning shampoo 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:  Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use VetraSeb™ CeraDerm™ P Mousse.

WARNINGS AND PRECAUTIONS SECTION

CAUTIONS: For external use on dogs and 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

Available only through your veterinarian.

Distributed by: MWI

Boise, Idaho 83705

www.VetOne.net

QUESTIONS?

1-800-999-0297

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VetOne®

VetraSeb™ CeraDerm™ P

Conditioning Shampoo

Pramoxine HCl 1%

Soothing Anti-itch Conditioning Shampoo for Dogs or Cats

CUCUMBER MELON

For veterinary use only

Net Contents: 8 FL. OZ. (237 mL)

8 ounce bottle label8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VetOne®

VetraSeb™ CeraDerm™ P

Conditioning Shampoo

Pramoxine HCl 1%

Soothing Anti-itch Conditioning Shampoo for Dogs or Cats

CUCUMBER MELON

For veterinary use only

Net Contents: 16 FL. OZ. (473 mL)

16 ounce bottle label16 ounce bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1244963pramoxine HCl 1 % Medicated ShampooPSN1
1244963pramoxine hydrochloride 10 MG/ML Medicated ShampooSCD1
1244963pramoxine hydrochloride 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-438-08VetraSeb CeraDermP237 mL in 1 BOTTLE, PLASTICSHAMPOO2371
13985-438-16VetraSeb CeraDermP473 mL in 1 BOTTLE, PLASTICSHAMPOO4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-438VETRASEB CERADERM P (PRAMOXINE HYDROCHLORIDE) SHAMPOO [MWI/VETONE]12 package rows20210407_fca6ae64-67c9-41d8-8747-15f741dec916.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-43813985-438-08, 13985-438-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
SODIUM CHLORIDE451W47IQ8XIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LACTATETU7HW0W0QTIACT
AVENANTHRAMIDES5PA41O4AITIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE EOSCR0J8RN66KIACT
CERAMIDE NP4370DF050BIACT
SAFFLOWER OIL65UEH262ISIACT
PEG-8 LAURATE762O8IWA10IACT
LAURETH-46HQ855798JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
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.