NDC 54973-4003 Poison Ivy And Poison Oak Relief

Croton Tiglium Seed, Toxicodendron Pubescens Leaf And Xerophyllum Asphodeloides

NDC Product Code 54973-4003

NDC CODE: 54973-4003

Proprietary Name: Poison Ivy And Poison Oak Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Croton Tiglium Seed, Toxicodendron Pubescens Leaf And Xerophyllum Asphodeloides What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
5 MM
Score: 1

NDC Code Structure

  • 54973 - Hyland's
    • 54973-4003 - Poison Ivy And Poison Oak Relief

NDC 54973-4003-1

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET in 1 BOTTLE

NDC Product Information

Poison Ivy And Poison Oak Relief with NDC 54973-4003 is a a human over the counter drug product labeled by Hyland's. The generic name of Poison Ivy And Poison Oak Relief is croton tiglium seed, toxicodendron pubescens leaf and xerophyllum asphodeloides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Poison Ivy And Poison Oak Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TOXICODENDRON PUBESCENS LEAF 6 [hp_X]/1
  • CROTON TIGLIUM SEED 9 [hp_X]/1
  • XEROPHYLLUM ASPHODELOIDES 6 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACACIA (UNII: 5C5403N26O)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hyland's
Labeler Code: 54973
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Poison Ivy And Poison Oak Relief Product Label Images

Poison Ivy And Poison Oak Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Purpose

Croton Tig 9X HPUS...........................................................itching, oozing eruptionsRhus Tox 6X HPUS...........red, swollen eruptions with itching, followed by crustingXerophyllum 6X HPUS...............................itching, stinging, burning skin irritations"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

  • Temporarily relieves the following symptoms after contact with poison ivy or poison oak:red, swollen eruptions itchy, stinging or burning skin irritationswatery blisters sometimes followed by oozing or crusting

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Other

Do not use more than directed.

Consult a physician if symptoms such as irritation, pain or redness persist for more than 7 days or worsen.

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Directions

Adults and children

12 years and over
Dissolve 2-3 tablets under tongue every 2 hoursfor up to 4 doses, then every 4 hours until relieved.Children 6 years to

under 12 years
Dissolve 1-2 tablets under tongue every 2 hours

for up to 4 doses, then every 4 hours until relieved.
Children under 6 yearsConsult a physician.

Other Information

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive Ingredients

Acacia Gum, Lactose.

*Claims Based On Traditional Homeopathic Practice, Not Accepted Medical Evidence. Not Fda Evaluated.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

* Please review the disclaimer below.