NDC 0363-3233 Walgreens Earache Drops

Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens, And Sulfur

NDC Product Code 0363-3233

NDC CODE: 0363-3233

Proprietary Name: Walgreens Earache Drops 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: Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens, And Sulfur 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

  • 0363 - Walgreen Company

NDC 0363-3233-15

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

NDC Product Information

Walgreens Earache Drops with NDC 0363-3233 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Earache Drops is belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur. The product's dosage form is liquid and is administered via auricular (otic) form.

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.

Walgreens Earache Drops 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.


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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • 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: Walgreen Company
Labeler Code: 0363
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: 06-22-2021 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: 12-31-2022 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 - NO 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.

Walgreens Earache Drops 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 ingredientsPurposeBelladonna 30C HPUSFever Calcarea Carbonica 30C HPUSThrobbing ear painChamomilla 30C HPUSSleeplessness and irritabilityLycopodium 30C HPUSEar painPulsatilla 30C HPUSEar itching, pain worse at nightSulphur 30C HPUSEar pain with burning"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

Belladonna -
Fever
Calcarea carbonica -
Throbbing ear pain
Chamomilla -
Sleeplessness and irritability
Lycopodium -
Ear pain Pulsatilla - Ear itching, pain worse at night
Sulphur -
Ear pain with burning

Uses

Uses*• For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmer’s ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. • Keep away from eyes. • Do not take by mouth. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur. • A Physician should always be consulted to rule out serious causes. • If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Otc - Pregnancy Or Breast Feeding

• If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Do Not Use

Do not use: • If you have ear drainage, irritation, discharge or rash in the ear, consult a physician • With ear tubes, damaged ear drums or after surgery. • If drops become cloudy.

Otc - Stop Use

Stop use and ask a doctor if:• Symptoms worsen or continue for more than 48 hours. • There is discharge from the ear. • A fever greater than 102o F is present.

Directions

DirectionsSuitable for adults and children overtheageof2.•Forusein the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops four times per day or as needed.• Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 1 – 2 minutes or gently place cotton in the ear to keep drops in.

Other Information

Active ingredients are micro diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. • Store at 15
o C - 30
o C (59
o F-86
o F ). • Protect from light and excessive moisture.

Inactive Ingredients

Benzalkonium chloride, Citric acid, Glycerin, Purified water.

* Please review the disclaimer below.