NDC 68703-322 Earstill

Calc Fluor, Carboneum Sulph, Chininum Sulph, Mang Met, Salicylicum Ac

NDC Product Code 68703-322

NDC 68703-322-02

Package Description: 59 mL in 1 BOTTLE, GLASS

NDC Product Information

Earstill with NDC 68703-322 is a a human over the counter drug product labeled by Silver Star Brands. The generic name of Earstill is calc fluor, carboneum sulph, chininum sulph, mang met, salicylicum ac. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Silver Star Brands

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.

Earstill 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.

  • CARBON DISULFIDE 6 [hp_C]/59mL
  • SALICYLIC ACID 6 [hp_C]/59mL
  • QUININE SULFATE 6 [hp_C]/59mL
  • MANGANESE 6 [hp_C]/59mL
  • CALCIUM FLUORIDE 30 [hp_C]/59mL

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)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Silver Star Brands
Labeler Code: 68703
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: 03-04-2019 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: 12-31-2020 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.

Earstill 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

Hpus Active Ingredients

HPUS Active Ingredients: Equal volumnes of each ingredient: Calc fluor 30C, Carboneum sulph 6C, Chininum sulph 6C, Mang met 6C, Salicylicum ac 6C.

Uses*:

Uses*: Homeopathic remedy to relieve occasional ringing and buzzing in the ears.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

Warnings

Warnings: If symptoms persist or worsen, consult a healthcare professional.
If pregnant or breastfeeding, ask a healthcare professional before use.
Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions: Mix in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into the mouth. Adults & children 12+: Take 0.50 mL every hour for 6 doses. Thereafter, use as needed until symptoms improve.

Other Safety Information

Contains no artificial flavors or colorants. No gluten added.Tamper resistant for your protection. Use only if safety seals is intact.

Inactive Ingredients

Inactive Ingredients: Grain alcohol (20% by volume), USP Purified water

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Purpose

Relieves occasional ringin, roaring, & buzzing sounds*

* Please review the disclaimer below.

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