FDA.reportPublic FDA data

POISON OAK AND IVY

Manufacturer
DeMartini Spring Hill Pharmacy, Inc. | Spa de Soleil
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:58

Label at a glance#

ProductPOISON OAK AND IVY
Active ingredientHYDROCORTISONE, PHENOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

HYDROCORTISONE (1%)

PHENOL (0.538%)

OTC - PURPOSE SECTION

PURPOSE

EXTERNAL ANALGESIC

ASTRINGENT

INDICATIONS & USAGE SECTION

USES: POISON OAK, POISON SUMAC, POISON IVY, MOSQUITO BITES, OTHER ALLERGIC RASHES.

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON EEP OR PUNCTURE WOUNDS, ANIMAL BITES, OR SERIOUS BURNS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP ORCONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR USE: APPLY DIRECTLY TO THE RASH AREA 3 TO 5 TIMES DAILY OR AS NEEDED FOR THE RELIEF OF ITCHING, REDNESS OR WEEPING.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: SD Alcohol 40-B, Aqua, Witch Hazel Distillate, Alcohol (Ethanol-Natural Grain USP), Acrylates/C10-30, Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, *CO Aloe Vera Leaf Powder, Citrus Limon (Lemon) Peel Oil, Benzyl Alcohol, Blue 1 *CO certified organic

OTC - WHEN USING SECTION

When using this product
• Avoid getting in eyes or mucus membranes. If contact occurs rinse thoroughly with water.
• Discontinue use if allergic to any of the components.

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Picture1Picture1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57479-102-012025-01-30C16284748780-12cef2736-67a1-d83d-e063-dadaa90ab31f03aeed00-2027-0b57-e063-6394a90a8b47

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57479-102-01POISON OAK AND IVY103 mL in 1 TUBEGEL1031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57479-102POISON OAK AND IVY (HYDROCORTISONE, PHENOL) GEL [DEMARTINI SPRING HILL PHARMACY, INC.]11 package rows20230825_03aeed00-2027-0b57-e063-6394a90a8b47.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57479-10257479-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LEMON JUICEAGN709ANTJIACT
WITCH HAZEL101I4J0U34IACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
WATER059QF0KO0RIACT
HYDROCORTISONEWI4X0X7BPJACTIB
PHENOL339NCG44TVACTIB

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
03aeed00-2028-0b57-e063-6394a90a8b4703aeed00-2027-0b57-e063-6394a90a8b472023-08-24WarningsExact identifier
spl id: 03aeed00-2028-0b57-e063-6394a90a8b47
spl set id: 03aeed00-2027-0b57-e063-6394a90a8b47

Reported adverse events (FAERS/openFDA)#

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