FDA.reportPublic FDA data

Promoxine Anti Itch

Manufacturer
Davis Manufacturing and Packaging Inc | Vanessa Solis
Effective date
2019-11-06
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:40:34

Label at a glance#

ProductPramoxine Anti Itch
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Davis Pramoxine Anti-ItchTM Shampoo helps to provide rapid, temporary relief from pruritis caused by a variety of dermatologic conditions. The safe, fast acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent to aid in alleviating itching and discomfort. Colloidal Oatmeal and moisture-rich emollients condition the skin and help prevent future dryness and flaking while Omega-6 fatty acids provide dermal nourishing. Davis Pramoxine Anti-Itch Shampoo is gentle enough for frequent use and leaves the coat with a healthy shine and pleasant scent.

SPL UNCLASSIFIED SECTION

Environment Friendly

MADE IN THE USA

Davis Manufacturing

541 Proctor Avenue

Atlanta/Scottdale, GA 30079

www.davismfg.com

800-292-2424

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Pramoxine Hydrochloride 1.0%

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Ceterimenium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, Colloidal Oatmeal, Triethenolamine, Herbal Fragrance, FD&C Yellow #5, Chocolate Dye

INSTRUCTIONS FOR USE SECTION

DIRECTIONS FOR USE

Wet coat thoroughly with warm water.  Apply shampoo to head ears, then lather.  Do not get shampoo into eyes or nose.  Repeat procedure with neck, chest, middle and hindquarters, finishing with legs.  Allow shampoo to be absorbed for 5 to 10 minutes then rinse thoroughly.  May be used as often as necessary or as directed by a veterinarian.  For optimal results, use in conjunction with Davis Pramoxine Anti-Itch TM Creme Rinse.  For added benefit between baths, apply Pramoxine Anti-Itch TM Spray to localized areas.

PRECAUTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For External Use Only

Keep Out of Reach of Children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Pramoxine Anti-Itch TM Shampoo
With 1% Pramoxine Hydrochloride
For Dogs, Cats, Puppies and Kittens
Anti-pruritic formula alleviates scratching and flaking associated with seborrhea dermatitis and other skin disorders

12 Fl. Oz. (355 ml)

PSH12PSH12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis

Veterinary Products

Pramoxine

Anti-Itch TM

Shampoo

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)

PSHGPSHG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1244963pramoxine HCl 1 % Medicated ShampooPSN3
1244963pramoxine hydrochloride 10 MG/ML Medicated ShampooSCD3
1244963pramoxine hydrochloride 1 % Medicated ShampooSY3

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
62570-101-01Pramoxine Anti Itch3785 g in 1 BOTTLESHAMPOO37853
62570-101-12Pramoxine Anti Itch355 g in 1 BOTTLESHAMPOO3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62570-101PRAMOXINE ANTI ITCH (PRAMOXINE HYDROCHLORIDE) SHAMPOO [DAVIS MANUFACTURING AND PACKAGING INC]32 package rows20191108_2b846bf6-eb1f-4934-8f4d-5ad65e19db90.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62570-10162570-101-12, 62570-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
OATMEAL8PI54V663YIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT

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.