NDC 71753-8001 Calcarea Fluorica

Calcarea Fluorica

NDC Product Code 71753-8001

NDC 71753-8001-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Calcarea Fluorica with NDC 71753-8001 is a a human over the counter drug product labeled by Ratis, Llc. The generic name of Calcarea Fluorica is calcarea fluorica. The product's dosage form is spray and is administered via oral form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Calcarea Fluorica 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.

  • 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: Ratis, Llc
Labeler Code: 71753
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: 09-30-2020 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 - 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.

Calcarea Fluorica Product Label Images

Calcarea Fluorica 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 Ingredient:

Calcarea Fluorica 12X.

Uses:

Supports the health and elasticity of bones, teeth, skin, joints, muscles, and veins.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

For oral use only.If pregnant or breast-feeding, or if symptoms persist or worsen, ask a health care professional.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults: 2 sprays 3 times a day or as needed.Children 2-12: 1 spray as above. For children 12 and under, consult a doctor.

Indications:

Supports the health and elasticity of bones, teeth, skin, joints, muscles, and veins.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients:

Demineralized Water, Organic Ethanol 20%

Questions:

Comments? VisitHomeopathyStore.comor call (888) 405-7551.Distributed by:Ratis, LLC,211 E. Lombard St, STE 303,Baltimore, MD 21202

Package Label Display:

NDC 71753-8001-1LACTOSE FREEAnna'sREMEDIESCalcarea FluoricaHOMEOPATHIC ORAL SPRAY1 FL. OZ (30ML)

* Please review the disclaimer below.