FDA.reportPublic FDA data

GlenHaven Benasoothe

Manufacturer
GlenHaven LLC | Dechra Veterinary Products
Effective date
2021-12-09
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:41:11

Label at a glance#

ProductGlenHaven Benasoothe
Active ingredientPRAMOXINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

VETERINARY INDICATIONS SECTION

Benasoothe Shampoo is a moisturizing shampoo which promotes relief of itchy, irritated skin in cats and dogs. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION SECTION

ACTIVE INGREDIENTS: 1% Pramoxine HCL USP, 1% Diphenhydramine HCL USP

SPL UNCLASSIFIED SECTION

ALSO CONTAINS: Water, Sodium C14-16 Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Laureth Sulfate, Glycol Stearate, Fragrance, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Cocos Nucifera (Coconut) Oil, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Shake well before use. Apply to wet coat, and massage into coat to create a lather. Wait 5-10 minutes, then rinse well. Use daily or as directed by your veterinarian. For best results, follow with Glenhaven Benasoothe Conditioner after bathing and between baths to soothe irritated skin.

WARNINGS SECTION

CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets. Wash hands after use.

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

STORAGE: Store at controlled room temperature of 20-25° C (68-77° F).

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians only.

Manufactured for:
GlenHaven
PO Box 13998
8000 NE Tillamook St.
Portland, OR 97213

53243 REV01/17

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70782-201-12

GlenHaven™
Therapeutics

Medically Formulated

Benasoothe
Shampoo

New Improved Formulation
Formerly A2/S

Soothing,
relieves itching

Pramoxine HCL,
diphenhydramine HCL

For Dog and Cat Use Only

Net Contents: 12 FL OZ. (355 mL)

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2564015diphenhydrAMINE HCl 1 % / pramoxine HCl 1 % Medicated ShampooPSN2
2564015diphenhydramine hydrochloride 10 MG/ML / pramoxine hydrochloride 10 MG/ML Medicated ShampooSCD2
2564015diphenhydramine HCl 1 % / pramoxine HCl 1 % Medicated ShampooSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70782-201-12GlenHaven Benasoothe355 mL in 1 BOTTLESHAMPOO3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70782-201GLENHAVEN BENASOOTHE (PRAMOXINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE) SHAMPOO [GLENHAVEN LLC]21 package rows20211212_99cb388e-ed5f-4c4e-9b26-1dc99f875b79.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70782-20170782-201-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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.