FDA.reportPublic FDA data

Davis Pramoxine Anti-Itch

Manufacturer
Davis Manufacturing and Packaging Inc | Vanessa Solis
Effective date
2018-04-27
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:16

Label at a glance#

ProductDavis Pramoxine Anti-Itch
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Davis Pramoxine Anti-ItchTM Creme Rinse helps to provide rapid, temporary relief from pruitis caused by a variety of dermatologic conditions while renourishing the skin and leaving the coat more manageable.  The safe, fast-acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent that aids in alleviating itching and discomfort.  Colloidal Oatmeal and moisture-rich emollients condition and nourish the skin and help prevent future dryness and flaking.

SPL UNCLASSIFIED SECTION

Made in the USA

Manufactured by:

Davis Manufacturing 

541 Proctor Avenue

Scottdale, GA 30079

www.davismfg.com

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Pramoxine Hydrochloride 1.0%

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Cetrimonium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, FD&C Yellow #5, Chocolate Dye

INSTRUCTIONS FOR USE SECTION

DIRECTIONS FOR USE

After shampooing and thoroughly rinsing, aplly creme rinse over the entire coat.  Rub in Well.  Do not get into eyes or nose.  Allow creme rinse to be absorbed for 5 to 10 minutes before lightly rinsing.  For residual results, do not rinse and use as a leave on conditioner.  May be used as often as necessary or as directed by a veterinarian.

PRECAUTIONS SECTION

If contact with eyes or nose occurs, rinse thoroughly.  If irritation or redness presists or increases, discontinue use and consult a veterinarian.

For External Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach

of Children and Pets

Gallon display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis Veterinary Products

Pramoxine

Anti-ItchTM

Creme Rinse

With 1% Pramoxine Hydrochloride

For Dogs, Cats, Puppies and Kittens

Anti-pruritic formula alleviates

scratching and flaking associated with 

seborrhea dermititis and other skin disorders.

1 Gallon (3.785 Liters)

GallonGallon

355 ml size

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis Veterinary Products

Pramoxine

Anti-ItchTM

Creme Rinse

With 1% Pramoxine Hydrochloride

For Dogs, Cats, Puppies and Kittens

Anti-pruritic formula alleviates

scratching and flaking associated with

seborrhea dermititis and other skin disorders.

12 Fl. Oz. (355 ml)

355 ml355 ml

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
62570-100-01Davis Pramoxine Anti-Itch3785 g in 1 JUGLOTION/SHAMPOO37851
62570-100-12Davis Pramoxine Anti-Itch355 g in 1 BOTTLELOTION/SHAMPOO3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62570-100DAVIS PRAMOXINE ANTI-ITCH (PRAMOXINE) LOTION/SHAMPOO [DAVIS MANUFACTURING AND PACKAGING INC]12 package rows20180626_c5ad713b-2d9d-42e9-bd18-44236786b930.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62570-10062570-100-12, 62570-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 45:10:45; 1200000 MW)F11YNO8FDQIACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
TROLAMINE9O3K93S3TKIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
oatmeal8PI54V663YIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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.