NDC 59262-278 Swimmers Ear Relief

Anemone Pulsatilla, Graphite And Sulfur

NDC Product Code 59262-278

NDC 59262-278-11

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Swimmers Ear Relief with NDC 59262-278 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Swimmers Ear Relief is anemone pulsatilla, graphite and sulfur. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Similasan Corporation

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Swimmers Ear 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.

  • ANEMONE PULSATILLA 12 [hp_X]/mL
  • GRAPHITE 12 [hp_X]/mL
  • SULFUR 12 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

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

Labeler Name: Similasan Corporation
Labeler Code: 59262
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: 12-15-2020 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.

Swimmers Ear 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

Active Ingredients

Pulsatilla 12X

Graphites 12X

Sulphur 12X

Purpose

Pain in ears, humming

Blocked sensation in ears

Itchiness, sensitivity to water

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve swimmer’s ear symptoms such as:• pain in ears, humming• blocked sensation in ears• itchiness, sensitivity to water

Warnings

• Do not use in the eyes.• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If:

• symptoms persist for more than 48 hours• there is discharge from the ear• there is a fever of 102°F or greater

Ask A Doctor Before Use If You Have:

• ear drainage or discharge• pain, irritation, or rash in the ear• had ear surgery• dizziness

Directions

FOR USE IN THE EAR ONLY.• Remove tamper-evident seal from neck of bottle.• Twist cap off bottle.• Tilt head sideways.• DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.• Children under 12 years of age consult a doctor.

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredient

Purified water, Vegetable glycerin

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.comwww.SimilasanUSA.com

* Please review the disclaimer below.