NDC 57955-0921 Eczema Symptom Relief

Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale

NDC Product Code 57955-0921

NDC Code: 57955-0921

Proprietary Name: Eczema Symptom 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: Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale 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

  • 57955 - King Bio Inc.
    • 57955-0921 - Eczema Symptom Relief

NDC 57955-0921-3

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Eczema Symptom Relief with NDC 57955-0921 is a a human over the counter drug product labeled by King Bio Inc.. The generic name of Eczema Symptom Relief is cardiospermum, hydrastis canadensis, hydrocotyle asiatica, lappa major, rhus tox, rumex crispus, ruta graveolens, sanguinaria canadensis, taraxacum officinale. The product's dosage form is cream and is administered via topical form.

Labeler Name: King Bio Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Eczema Symptom 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.

  • CARDIOSPERMUM HALICACABUM FLOWERING TOP 2 [hp_X]/85g
  • GOLDENSEAL 10 [hp_X]/85g
  • CENTELLA ASIATICA 10 [hp_X]/85g
  • ARCTIUM LAPPA ROOT 10 [hp_X]/85g
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/85g
  • RUMEX CRISPUS ROOT 10 [hp_X]/85g
  • RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X]/85g
  • SANGUINARIA CANADENSIS ROOT 10 [hp_X]/85g
  • TARAXACUM OFFICINALE 10 [hp_X]/85g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OATMEAL (UNII: 8PI54V663Y)
  • CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • LICORICE (UNII: 61ZBX54883)
  • AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
  • MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
  • ALCOHOL (UNII: 3K9958V90M)
  • RICE BRAN (UNII: R60QEP13IC)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: King Bio Inc.
Labeler Code: 57955
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: 03-01-2017 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: 12-31-2018 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: E 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.

Eczema Symptom Relief Product Label Images

Eczema Symptom 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

Otc - Active Ingredient

Drug Facts__________________________________________________________________________________________________________HPUS active ingredient                                                                  Purpose†  Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.Active ingredients 50% of total weight.Cardiospermum* (2X, 10X, 20X, 30X), Hydrastis canadensis*, Hydrastis canadensis*, Lappa major*, Rhus tox*, Rumex crispus*, Ruta graveolens*, Sanguinaria canadensis*, Taraxacum officinale*.*Certified organic Ingredient**"HPUS"indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses for temporary relief of eczema: •redness •intense itching •allergic skin eruptions •dry or moist eruptions •thickened, crusty, scaly skin •inflamed skin •general unhealthy skin

Warnings

  • WarningsFor external use only. Avoid contact with eyes and broken skin.Stop use and ask a doctor if  •increased skin irritation or other allergic reaction develops. •symptoms worsen or do not improve within 7 days.Nursing mothers should not apply to breast area.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions•Shake before using. •Adults & children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. •Children under 2 years of age: consult a doctor. •Patch test recommended on sensitive skin.

Other Safety Information

  • Other information:To open: unscrew cap, remove tube seal, replace cap.Safety sealed for your protection.Do not use if tube seal is missing.Store at 68-77° (20-25°C).Certified organic topical lotion.

Inactive Ingredient

Inactive ingredients:​ Aloe vera leaf juice powder*, avena sativa oat kernel flour*, carrageenan, chamomile​ recutita flower extract*, citrus extract*, glycerin, green tea extract*, honeysuckle extract*, lecithin*, licorice root extract*, neem seed oil*, oregon grape root extract*, organic alcohol*, oryza sativa race bran extract*, silicon dioxide, sucrose cocoate, sunflower oil*, water, xanthan gum.*Certified organic Ingredient. Certified organic by Oregon Tilth.

Otc - Purpose

__________________________________________________________________________________________________________HPUS active ingredient                                                              Purpose†Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.Active ingredients 50% of total weight. Cardiospermum (2X, 10X, 20X, 30X)......................................................allergic skin eruptionHydrastis canadensis..............................................................general unhealthy skin, eczemaHydrocotyle asiatica.................................dry, eruptions, thickening of skin, exfoliation of scalesLappa major...................................................................moist eruptions, greyish white crustsRhus tox........................................red, swollen, burning eczematous eruptions, scale formationRumex crispus.................................................................................intense itching, skin rashRuta graveolens......................................................................itching, inflamed, deep red skinSanguinaria canadensis...........................................................................redness and burningTaraxacum officinale....................................................severe itching, skin rash, unhealthy skin

* Please review the disclaimer below.

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