FDA.reportPublic FDA data

Disposable Hygiene Anti-itching Cream 80 mL

Manufacturer
Disposable Hygiene LLC dba Anthem
Effective date
2022-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:24

Label at a glance#

ProductHoney Pot
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1% (w/w)

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product: avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if: • Condition worsens • If symptoms persist for more than 7 days, or clear up and reoccur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 mL NDC: 71505-022-8080 mL NDC: 71505-022-80

80 mL NDC: 71505-022-80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294036pramoxine HCl 1 % Topical SprayPSN1
1294036pramoxine hydrochloride 10 MG/ML Topical SpraySCD1
1294036pramoxine hydrochloride 1 % Topical SpraySY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71505-022-802023-07-28C16284748780-10191ceaa-665c-198a-e063-dbdaa90aec3eDisposable Hygiene Anti-itching Cream 80 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71505-022-80Honey Pot80 mL in 1 BOTTLELIQUID801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71505-022HONEY POT (ANTI-ITCH SOOTHING) LIQUID [DISPOSABLE HYGIENE LLC DBA ANTHEM]1Legacy NDC, 1 package rows20220429_ddc4f5ad-9ed9-cc1a-e053-2a95a90a8668.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71505-02271505-022-80

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
ACETIC ACIDQ40Q9N063PIACT
SODIUM HYDROXIDE55X04QC32IIACT
LAVENDER OILZBP1YXW0H8IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GARLIC OIL4WG8U28833IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
ALOE VERA LEAFZY81Z83H0XIACT
WITCH HAZEL101I4J0U34IACT
HONEYY9H1V576FHIACT
CUCUMBER FRUIT OILR81Y52NPCTIACT
COCONUT OILQ9L0O73W7LIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
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
ddc4f5ad-9ed8-cc1a-e053-2a95a90a8668ddc4f5ad-9ed9-cc1a-e053-2a95a90a86682022-02-15WarningsExact identifier
spl id: ddc4f5ad-9ed8-cc1a-e053-2a95a90a8668
spl set id: ddc4f5ad-9ed9-cc1a-e053-2a95a90a8668

Reported adverse events (FAERS/openFDA)#

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