Ear Wax Relief

Causticum, Graphite, Lachesis Muta Venom And Lycopodium Clavatum Spore

Similasan Corporation
Human Otc Drug
NDC 59262-272

Ear Wax Relief also known as Causticum, Graphite, Lachesis Muta Venom And Lycopodium Clavatum Spore is a human otc drug labeled by 'Similasan Corporation'. National Drug Code (NDC) number for Ear Wax Relief is 59262-272. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Ear Wax Relief drug includes Causticum - 12 [hp_X]/10mL Graphite - 15 [hp_X]/10mL Lachesis Muta Venom - 12 [hp_X]/10mL Lycopodium Clavatum Spore - 12 [hp_X]/10mL . The currest status of Ear Wax Relief drug is Active.

Drug Information:

Drug NDC:	59262-272
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Ear Wax Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Causticum, Graphite, Lachesis Muta Venom And Lycopodium Clavatum Spore
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Similasan Corporation
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CAUSTICUM - 12 [hp_X]/10mL GRAPHITE - 15 [hp_X]/10mL LACHESIS MUTA VENOM - 12 [hp_X]/10mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/10mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	AURICULAR (OTIC)
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Jun, 2003
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Similasan Corporation
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	DD5FO1WKFU 4QQN74LH4O VSW71SS07I C88X29Y479
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
59262-272-11	10 mL in 1 BOTTLE, DROPPER (59262-272-11)	01 Jun, 2003	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Ear Wax Relief

Causticum, Graphite, Lachesis Muta Venom And Lycopodium Clavatum Spore

Solution
Similasan Corporation
NDC: 59262-272

Purpose:

Purpose itching, wax build-up

Purpose dryness, wax build-up

Purpose wax build-up

Product Elements:

Ear wax relief causticum, graphite, lachesis muta venom and lycopodium clavatum spore causticum causticum graphite graphite lachesis muta venom lachesis muta venom lycopodium clavatum spore lycopodium clavatum spore glycerin

Indications and Usage:

Uses: according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: clogged sensation when caused by ear wax ringing in the ear when caused by ear wax dry skin and itching of the ear canal

Warnings:

Warnings: according to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms). avoid contact with eyes. if pregnant, trying to get pregnant or breast feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. do not use: if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor for more than 48 hours; if excessive ear wax remains after the use of this product, consult a doctor with ear tubes

Do Not Use:

Dosage and Administration:

Directions: for use in the ear only. for adults and children, over 12 years of age: remove tamper evident seal from neck of bottle. twist cap off bottle. tilt head sideways, squeeze plastic applicator to release 2-3 drops into ear. (tip of applicator should not enter ear canal). keep drops in ear for 3-5 minutes by keeping head tilted or placing cotton in ear. any excess drops can be wiped away from outer ear. use twice daily for up to 2 days if needed, or as directed by a doctor. any wax remaining after treatment may be removed by with warm water, using a soft, rubber bulb ear syringe. children under 12 years of age: consult a doctor.

Package Label Principal Display Panel:

Principle display panel ndc 59262-272-11 similasan ear wax relief ear drops 10 ml / 0.33 fl oz ndc 59262-272-11 similasan ear wax relief ear drops 10 ml / 0.33 fl oz

Further Questions:

Questions? reach our representatives at: 1-800-240-9780 or getinfo@similasanusa.com www.similasanusa.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.