FDA.reportPublic FDA data

Oncoderm ItchRx Spray

Manufacturer
ONCODERM LABS, LLC
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:26:03

Label at a glance#

ProductOncoderm ItchRx
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL 1.00%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain (and itching) associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water, Calendula Officinalis Extract, Chamomilla Recutita (Chamomile)  Extract, Gluconolactone, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Methylsulfonylmethane (MSM), Punica Granatum (Pomegranate) Extract, Saccharide Isomerate, Sodium Benzoate, Urea, Zemea, (Corn) Propanediol, Zinc Acetate.

Comments?

OTC - QUESTIONS SECTION

Call: (833) 662-6522 or email: help@oncodermlabs.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75087-14175087-141-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POMEGRANATE56687D1Z4DIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SODIUM BENZOATEOJ245FE5EUIACT
UREA8W8T17847WIACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
ZINC ACETATEFM5526K07AIACT
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
07498bec-2432-7df5-e063-6294a90a4a9239e63168-8ed1-4034-a72d-02e2ffd4f9522023-10-09WarningsExact identifier
spl set id: 39e63168-8ed1-4034-a72d-02e2ffd4f952

Reported adverse events (FAERS/openFDA)#

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