H-arthritis Formula
Apium Graveolens, Arnica Montana
Healing Natural Oils Llc
Human Otc Drug
NDC 61077-034H-arthritis Formula also known as Apium Graveolens, Arnica Montana is a human otc drug labeled by 'Healing Natural Oils Llc'. National Drug Code (NDC) number for H-arthritis Formula is 61077-034. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in H-arthritis Formula drug includes Arnica Montana - 12 [hp_C]/11mL Celery Seed - 12 [hp_C]/11mL . The currest status of H-arthritis Formula drug is Active.
Drug Information:
| Drug NDC: | 61077-034 |
| 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: | H-arthritis Formula |
| 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: | Apium Graveolens, Arnica Montana |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Healing Natural Oils Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| 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: | ARNICA MONTANA - 12 [hp_C]/11mL
CELERY SEED - 12 [hp_C]/11mL
|
| 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: | UNAPPROVED HOMEOPATHIC |
| 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: | 06 Nov, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 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. |
| 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: | Healing Natural Oils LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | O80TY208ZW
1G1EAA320L
|
| 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 |
|---|
| 61077-034-11 | 11 mL in 1 BOTTLE, DROPPER (61077-034-11) | 06 Nov, 2013 | N/A | No |
| 61077-034-33 | 33 mL in 1 BOTTLE, DROPPER (61077-034-33) | 06 Nov, 2013 | 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 apium graveolens - 12c hpus (rheumatic pain), arnica montana -12c hpus (muscular tonic, joints, pain in back and limbs) the letters âhpusâ indicate that the components in this product are officially monographed in the homoeopathic pharmacopoeia of the united states
Product Elements:
H-arthritis formula apium graveolens, arnica montana celery seed celery seed arnica montana arnica montana european hazelnut oil frankincense oil juniper berry lavandula angustifolia flower chamomile white pepper oil thyme
Indications and Usage:
Indications: for the temporary relief of arthritis symptoms such as soreness, stiffness and inflammation.
Warnings:
Warnings: for external use only. perform skin test prior to initial use. do not use if pregnant or breastfeeding. keep out of reach of children. keep away from eyes and mucous membranes. if swallowed get medical help or contact a poison control center right away. discontinue use if irritation occurs. consult a doctor if symptoms worsen after 7 days.
Dosage and Administration:
Directions: adults and children 4 yrs and over: wash hands before and after use. shake well and apply 1 or 2 drops to fingers and massage directly to the affected area 3x per day. do not oversaturate or exceed dosage.
Stop Use:
Discontinue use if irritation occurs.
Description:
Dist. by healing natural oils 3830 valley ctr dr, #705-526, san diego, ca 92130, usa
Package Label Principal Display Panel:
Healing natural oils h-arthritis formula homeopathic for external use only 034 11ml (0.37 fl. oz) amoils.com arthritis label hno-labels-2017 14