NDC 53499-5190 Califlora

Calendula Officinalis

NDC Product Code 53499-5190

NDC 53499-5190-4

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC 53499-5190-8

Package Description: 1 TUBE in 1 CARTON > 78 g in 1 TUBE

NDC Product Information

Califlora with NDC 53499-5190 is a a human over the counter drug product labeled by Schwabe North America, Inc. The generic name of Califlora is calendula officinalis. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Califlora 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.

  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WITCH HAZEL (UNII: 101I4J0U34)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Schwabe North America, Inc
Labeler Code: 53499
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: 01-01-2006 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.

Califlora 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:CALENDULA OFFICINALIS 1X

Dosage & Administration

Boericke and Tafel Brand:Directions:For minor burns, first run cool water on the burn area and dry.For minor skin irritation, first wash the area with mild soap, rinse and dry.Adults and children 2 years of age and older:Apply to affected area.Repeat as necessary.Children under 2 years of age:Consult a doctorPatch test recommended on sensitive skin.

Indications & Usage

Indications and Use:Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.Helps promote healing of minor burns and skin irritations.

Otc - Purpose

Purpose:Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.Helps promote healing of minor burns and skin irritations.

Warnings

Warnings:For external use only.  Avoid contact with eyes.Do not use on broken skin.Do not use if hypersensitive to any ingredients in this product.Breast-feeding women shoud ot apply to breast area.In case of deep cuts or puncture wounds, animal bites or serious burns, consult a physician.Ask a doctor before use in case of deep cuts or puncture wounds, animal bites or serious burns.If swallowed, seek medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Ask Doctor

Ask the Doctor:Ask a doctor before use in case of deep cuts or puncture wounds, animal bites, or serious burns.

Otc - Pregnancy Or Breast Feeding

Pregnancy or Breast Feeding:Breast-feeding women should not apply to breast area.

Overdosage

Overdosage:If swallowed, seek medical help or contact a Poison Control Center immediately.

Boericke And Tafel Brandcalifloa Calendula Gel

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* Please review the disclaimer below.