Novarnica
Camphor And Menthol
Xcentrik Inc.
Human Otc Drug
NDC 61871-001Novarnica also known as Camphor And Menthol is a human otc drug labeled by 'Xcentrik Inc.'. National Drug Code (NDC) number for Novarnica is 61871-001. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Novarnica drug includes Camphor (natural) - 4 g/100mL Menthol - 8 g/100mL . The currest status of Novarnica drug is Active.
Drug Information:
| Drug NDC: | 61871-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Novarnica |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Camphor And Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Xcentrik Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CAMPHOR (NATURAL) - 4 g/100mL
MENTHOL - 8 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 22 Jan, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Xcentrik Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043494
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | N20HL7Q941
L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61871-001-01 | 1 BOTTLE in 1 CARTON (61871-001-01) / 65 mL in 1 BOTTLE | 22 Jan, 2014 | N/A | No |
| 61871-001-02 | 1 BOTTLE in 1 CARTON (61871-001-02) / 120 mL in 1 BOTTLE | 22 Jan, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Novarnica camphor and menthol camphor (natural) camphor (natural) menthol menthol arnica montana flower clove oil eucalyptus oil isopropyl alcohol peppermint oil polysorbate 20 water
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains
Warnings:
Warnings for external use only avoid contact with eyes and mucous membranes do not apply on wounds or damaged skin do not bandage tightly do not apply external heat such as an electric heating pad, as this may result in excessive skin irritation or skin burn do not apply on or near the nipple if pregnant or breastfeeding, ask a health professional before use do not inhale or swallow allergy alert: do not use if allergic to asteraceae/compositae/daisy family or to any other ingredient contained in this product flammable: keep away from fire or flame when using this product rashes and/or burning discomfort have been known to occur; in which case discontinue use. stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. keep safely out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
Dosage and Administration:
Directions adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a physician.
Package Label Principal Display Panel:
Principal display panel novarnica pain relieving spray with natural ingredients simple backache arthritis strains bruises sprains spray solution no rubbing fast acting 2.19 fl oz (65 ml) 2.19 fl oz (65 ml)
4.06 fl oz (120 ml) 4.06 fl oz (120 ml)
Further Questions:
Questions? if you have questions of a medical nature, please contact your pharmacist, doctor or health care professional xcentrik inc. 7902 samuel hatt chambly (quebec) canada j3l 6w4 1-800-441-5375 www.novarnica.com made in canada