NDC 57520-0521 Ear Inflammation Plus

NDC Product Code 57520-0521

NDC 57520-0521-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ear Inflammation Plus with NDC 57520-0521 is a product labeled by Apotheca Company. The generic name of Ear Inflammation Plus is . The product's dosage form is and is administered via form.

Labeler Name: Apotheca Company

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)
  • ALCOHOL (UNII: 3K9958V90M)

Product Labeler Information

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

Labeler Name: Apotheca Company
Labeler Code: 57520
Start Marketing Date: 06-24-2010 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ear Inflammation Plus Product Label Images

Ear Inflammation Plus 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

ACTIVE INGREDIENTS:  Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

Otc - Purpose

INDICATIONS:  For temporary relief of symptoms due to inflammation and pain of the ears.

Warnings

WARNINGS:  Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use.Do not use if tamper evident seal is broken or missing.

Dosage & Administration

DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

Inactive Ingredient

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

Otc - Questions

Distributed by:SYNERGY FORMULAS, INC.251 West RoadCampobello, SC 29322

* Please review the disclaimer below.