FDA.reportPublic FDA data

ProCure Medicated

Manufacturer
Twin Med LLC
Effective date
2025-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:35:40

Label at a glance#

ProductProCure Medicated
Active ingredientALUMINUM HYDROXIDE
Label structure7 sections

Indications and uses

Uses Dries the oozing and weeping of poison ivy, oak and sumac

Dosage and administration

Directions Apply as needed Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum Hydroxide Gel 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses

  • Dries the oozing and weeping of poison ivy, oak and sumac

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply as needed
  • Children under 6 months of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Cholecalciferol, Citric Acid, Ethylhexylglycerin, Glyceryl Monostearate, Glyceryl Stearate/ PEG-100 Stearate, Lanolin, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate,Stearyl Alcohol, Water, Zea Mays Corn Oil, Zinc Chloride

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not get into the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last 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

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCMG35 ImagePCMG35 Image

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-02955681-029-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZEA MAYS (CORN) OIL8470G57WFMIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LANOLIN7EV65EAW6HIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CALCIUM CARBONATEH0G9379FGKIACT
CHOLECALCIFEROL1C6V77QF41IACT
CITRIC ACID2968PHW8QPIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
RETINYL PALMITATE1D1K0N0VVCIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
ZINC CHLORIDE86Q357L16BIACT

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
3b919a5e-38b1-7519-e063-6294a90af70e39ebc17d-63c6-50d7-e063-6394a90aeeaa2025-08-04WarningsExact identifier
spl set id: 39ebc17d-63c6-50d7-e063-6394a90aeeaa

Reported adverse events (FAERS/openFDA)#

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