NDC 60512-9202 Teething Kids Relief Baby

NDC Product Code 60512-9202

NDC CODE: 60512-9202

Proprietary Name: Teething Kids Relief Baby 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.

Product Characteristics

Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 60512 - Homeolab Usa Inc

NDC 60512-9202-8

Package Description: 1 BOTTLE in 1 BOX > 25 mL in 1 BOTTLE

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

NDC Product Information

Teething Kids Relief Baby with NDC 60512-9202 is a product labeled by Homeolab Usa Inc. The product's dosage form is and is administered via form.

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)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Labeler Information

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

Labeler Name: Homeolab Usa Inc
Labeler Code: 60512
Start Marketing Date: 09-01-2016 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: 12-31-2019 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.

Teething Kids Relief Baby Product Label Images

Teething Kids Relief Baby 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 Hpus:

Chamomilla (German chamomile) 5CArnica montana (Leopard`s bane) 5CBorax (Sodium borate) 5CHypericum perforatum ( St John's wort) 5C

Purpose

Gum pain, restlessness, irritability and agitationToothache and feverGum inflammation and diarrheaDental nerve pain

References

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.RETAIN CARTON FOR COMPLETE INSTRUCTIONS

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*:• gum inflammation• gum pain• fever• diarrhea• restlessness and irritability

Otc - Do Not Use

Do not use if imprinted shrink seal under bottle cap is broken or missing.

Otc - Stop Use

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

Other Information

Store at room temperature.

Inactive Ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

* Please review the disclaimer below.