FDA.reportPublic FDA data

Pramox

Manufacturer
Animal Pharmaceuticals | Stratford Care Usa, Inc.
Effective date
2021-10-18
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:41:05

Label at a glance#

ProductPramox
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

a medicated shampoo for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.

Dosage and administration

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride , USP 1%

​Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Disodium Cocoamphodiacetate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Hydrolyzed Oats, Carthamus tinctorius (Safflower) Seed Oil, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone.

​Uses:

INDICATIONS & USAGE SECTION

a medicated shampoo for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.

​Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

​Precautions

PRECAUTIONS SECTION

For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

SPL UNCLASSIFIED SECTION

Anti-itch Shampoo

For Temporary Relief of Dermatological Conditions Responsive To Pramoxine.

Tropical Guava

Formulated for Dogs, Cats & Horses

At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond...and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

OUR ASSURANCE
Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

​ALL PRODUCTS ARE MADE IN THE U.S.A

To learn more about our products, visit:

​www.anmpharm.com

​SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

​MANUFACTURED FOR
Animal Pharmaceuticals

MADE IN THE USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
68898-124-16Pramox474 mL in 1 BOTTLE, PLASTICSHAMPOO4741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68898-124PRAMOX (PRAMOXINE HYDROCHLORIDE) SHAMPOO [ANIMAL PHARMACEUTICALS]11 package rows20211021_f6d0982b-fd33-4f01-b4d5-8fe7c235ee1c.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
68898-12468898-124-16

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
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LACTATETU7HW0W0QTIACT
OATZ6J799EAJKIACT
SAFFLOWER OIL65UEH262ISIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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.