FDA.reportPublic FDA data

CONTACT ALLERGY ANTIGEN

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:09

Label at a glance#

ProductCONTACT ALLERGY ANTIGEN
Active ingredientTOXICODENDRON DIVERSILOBUM LEAF, TOXICODENDRON PUBESCENS LEAF, TOXICODENDRON VERNIX LEAFY TWIG, URTICA DIOICA, SEMECARPUS ANACARDIUM FRUIT, GRAPHITE, DAPHNE MEZEREUM BARK, URTICA URENS, XEROPHYLLUM ASPHODELOIDES
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: Rhus Divers 9X, 12X, 15X, 30X, Rhus Tox 9X, 12X, 15X, 30X, Rhus Ven 9X, 12X, 15X, 30X, Urtica Di 9x, 12X, 15X, 30X, Anacard Or 12X, Graphites 12X, Mezereum 12X, Urtica Ur 12X, Xerophyllum 12X.

OTC - PURPOSE SECTION

USES: Temporarily relieves occasional skin irritation.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves occasional skin irritation.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0115-1

CONTACT ALLERGY ANTIGEN

HOMEOPATHIC

1 fl oz (3o mL) / 20% alcohol

UPC: 87773001047   NON GMO Logo

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0115-12022-01-28C16284748780-19d75b9d0-3583-f424-e053-dadaa90a57ceCONTACT ALLERGY ANTIGEN
43406-0115-12020-06-02C16284748780-19d75b9d0-3583-f424-e053-dadaa90a57ceCONTACT ALLERGY ANTIGEN
43406-0115-12020-01-31C16284748780-19d75b9d0-3583-f424-e053-dadaa90a57ceCONTACT ALLERGY ANTIGEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0115-1CONTACT ALLERGY ANTIGEN30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0115CONTACT ALLERGY ANTIGEN (TOXICODENDRON DIVERSILOBUM LEAF, TOXICODENDRON PUBESCENS LEAF, TOXICODENDRON VERNIX LEAFY TWIG, URTICA DIOICA, SEMECARPUS ANACARDIUM JUICE, GRAPHITE, DAPHNE MEZEREUM BARK, URTICA URENS, XEROPHYLLUM ASPHODELOIDES) LIQUID [NATURAL CREATIONS, INC.]2Legacy NDC, 1 package rows20200527_e17a8715-5e94-4d92-833f-9fb80f69abb7.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
43406-011543406-0115-1

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
TOXICODENDRON DIVERSILOBUM LEAFV727AWD6ZZACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
TOXICODENDRON VERNIX LEAFY TWIGY3VW699H96ACTIB
URTICA DIOICA710FLW4U46ACTIB
SEMECARPUS ANACARDIUM FRUIT7399B063X9ACTIB
GRAPHITE4QQN74LH4OACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
URTICA URENSIHN2NQ5OF9ACTIB
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
33da2e7d-edeb-4d1f-8761-d5be86cb3f69e17a8715-5e94-4d92-833f-9fb80f69abb72020-05-26WarningsExact identifier
spl id: 33da2e7d-edeb-4d1f-8761-d5be86cb3f69
spl set id: e17a8715-5e94-4d92-833f-9fb80f69abb7

Reported adverse events (FAERS/openFDA)#

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