ASTONEAGRAN

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:18

Label at a glance#

ProductASTONEAGRAN
Active ingredientALUMINUM HYDROXIDE
Label structure8 sections

Indications and uses

Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac, or other skin irritations

Dosage and administration

Apply liberally to affected area as needed or as directed by a physician ■Children under 6 months: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Aluminium Hydroxide Gel 2 % w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant


Uses:

INDICATIONS & USAGE SECTION

  • Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac, or other skin irritations

Warnings:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

■Deep or puncture wounds ■Animal bites ■Serious burns

Avoid contact with eyes. In case of contact, flush thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

■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


In case of accidental ingestion contact a physician or Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to affected area as needed or as directed by a physician ■Children under 6 months: ask a doctor

Other Information

OTHER SAFETY INFORMATION


■Store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Cholecalciferol, Citric Acid, DMDM Hydantoin, Ethylhexylglycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Zea Mays Corn Oil, Zinc Chloride

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-021-232024-06-25C16284748780-11030e365-27e7-111a-e063-dadaa90a10e2ASTONEA Gran
77338-021-232024-01-30C16284748780-11030e365-27e7-111a-e063-dadaa90a10e2ASTONEA Gran

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-021-23ASTONEAGRAN113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-021ASTONEAGRAN (ALUMINIUM HYDROXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 1 package rows20240627_e687a337-e87b-815c-e053-2995a90aeaff.zip

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
77338-02177338-021-23

Ingredients#

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

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

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
1bbb307e-90cb-85d5-e063-6394a90aff22e687a337-e87b-815c-e053-2995a90aeaff2024-06-25WarningsExact identifier
spl id: 1bbb307e-90cb-85d5-e063-6394a90aff22
spl set id: e687a337-e87b-815c-e053-2995a90aeaff

Reported adverse events (FAERS/openFDA)#

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