FDA.reportPublic FDA data

The Honey Pot Anti-Itch Soothing Spray

Manufacturer
The Honey Pot Company LLC
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:16:25

Label at a glance#

ProductAnti Itch Soothing 1 Pramoxine Hydrochloride
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching associated with minor skin irritations

Dosage and administration

Apply to affected not more than 3 or 4 times daily. Adults and children 12 years of age and older: Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose:

OTC - PURPOSE SECTION

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor skin irritations

Warnings:

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • If symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to affected not more than 3 or 4 times daily. Adults and children 12 years of age and older:

Children under 12 years of age: Consult a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Polysorbate 20, Glycerin, Pentylene Glycol, Hamamelis virginiana (Witch Hazel) Water, Benzoic Acid, Fragrance, Honey, Vinegar, Aloe Barbadensis Leaf Juice, Sodium Hydroxide, Cucumis Sativus (Cucumber) Fruit Extract, Lavender (Lavandula Angutifolia) Extract, Calendula Officinalis (Calendula) Flower Extract, Cocos Nucifera (Coconut) Fruit Extract, Allium Sativum (Garlic) Extract, Olea Europaea (Olive) Leaf Extract, Potassium Sorbate, Sodium Benzoate, Citric Acid

Other Information:

SPL UNCLASSIFIED SECTION

Store at a controlled room temperature 77°F (20-25°C).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294036pramoxine HCl 1 % Topical SprayPSN5
1294036pramoxine hydrochloride 10 MG/ML Topical SpraySCD5
1294036pramoxine hydrochloride 1 % Topical SpraySY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82637-9370-1Anti Itch Soothing 1 Pramoxine Hydrochloride1 in 1 CARTONSPRAY15
82637-9370-1Anti Itch Soothing 1 Pramoxine Hydrochloride80 mL in 1 BOTTLE, SPRAYSPRAY805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82637-9370ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE (PRAMOXINE HYDROCHLORIDE) SPRAY [THE HONEY POT COMPANY LLC]5Current NDC, Legacy NDC, 2 package rows20240802_8bfeea34-25d5-4721-a17f-d9f1d0084cc3.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
82637-937082637-9370-1

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
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
BENZOIC ACID8SKN0B0MIMIACT
HONEYY9H1V576FHIACT
ACETIC ACIDQ40Q9N063PIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
CUCUMBERYY7C30VXJTIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COCONUT3RT3536DHYIACT
GARLICV1V998DC17IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Itch Soothing 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC8bfeea34-25d5-4721-a17f-d9f1d0084cc32024-08-01WarningsExact identifier
ndc (package): 82637-9370-1
ndc (product): 82637-9370
ndc11 (package): 82637937001
spl id: 1ea19400-f1fe-b729-e063-6394a90a2e86
spl set id: 8bfeea34-25d5-4721-a17f-d9f1d0084cc3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.