NDC 54973-7511 Bug Bite

Apis Mellifera, Calendula Officinalis Flowering Top, Echinacea Angustifolia Root, Ledum Palustre Twig, And Urtica Dioica

NDC Product Code 54973-7511

NDC CODE: 54973-7511

Proprietary Name: Bug Bite 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: Apis Mellifera, Calendula Officinalis Flowering Top, Echinacea Angustifolia Root, Ledum Palustre Twig, And Urtica Dioica 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.

NDC Code Structure

NDC 54973-7511-1

Package Description: 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK > 8 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Bug Bite with NDC 54973-7511 is a a human over the counter drug product labeled by Hyland's. The generic name of Bug Bite is apis mellifera, calendula officinalis flowering top, echinacea angustifolia root, ledum palustre twig, and urtica dioica. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Hyland's

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Bug Bite 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.

  • APIS MELLIFERA 3 [hp_X]/8g
  • CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/8g
  • ECHINACEA ANGUSTIFOLIA ROOT 3 [hp_X]/8g
  • LEDUM PALUSTRE TWIG 3 [hp_X]/8g
  • URTICA DIOICA 3 [hp_X]/8g

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.

  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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: 01-01-1990 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: 12-31-2021 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.

Bug Bite Product Label Images

Bug Bite 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

Otc - Purpose

A homeopathic medicine for the temporary relief of symptoms of inflammation, pain and itching associated with bites and stings.

Inactive Ingredient

Apis Mell. 3X HPUS, Calendula Off. 3X HPUS, Echinacea Ang. 3X HPUS, Ledum Pal. 3X HPUS, Urtica Dioica 3X HPUS in a base of Petrolatum USP, Beeswax USP, Citronella Oil, Methylparaben USP, Propylparaben USP.

Directions

Wash affected area with lukewarm water and apply freely as needed; or as recommended by a licensed health care provider. Please note: it may take a few minutes to experience relief from Hyland's Bug Bite Ointment, but relief is long-lasting.

Warnings

For external use only. Avoid contact with eyes.

Otc - Do Not Use

Do not use if tamper band is broken or missing.

Otc - Ask Doctor/Pharmacist

If symptoms persist for more than 7 days or worsen, consult a licensed health care professional.

Otc - Keep Out Of Reach Of Children

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

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursing, seek the advice of a health care professional before using this product.

Otc - When Using

In case of accidental ingestion, contact a poison control center immediately. In case of emergency, the manufacturer may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Questions?

CALL US: 800-624-9659

* Please review the disclaimer below.