H-scars Formula
Calendula Officinallis, Silicea
Healing Natural Oils Llc
Human Otc Drug
NDC 61077-039H-scars Formula also known as Calendula Officinallis, Silicea is a human otc drug labeled by 'Healing Natural Oils Llc'. National Drug Code (NDC) number for H-scars Formula is 61077-039. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in H-scars Formula drug includes Calendula Officinalis Flowering Top - 12 [hp_C]/11mL Silicon Dioxide - 12 [hp_C]/11mL . The currest status of H-scars Formula drug is Active.
Drug Information:
| Drug NDC: | 61077-039 |
| 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-scars 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: | Calendula Officinallis, Silicea |
| 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: | CALENDULA OFFICINALIS FLOWERING TOP - 12 [hp_C]/11mL
SILICON DIOXIDE - 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: | 24 Dec, 2025 |
| 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: | 18E7415PXQ
ETJ7Z6XBU4
|
| 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 |
|---|
| 61077-039-11 | 11 mL in 1 BOTTLE, DROPPER (61077-039-11) | 06 Nov, 2013 | N/A | No |
| 61077-039-33 | 33 mL in 1 BOTTLE, DROPPER (61077-039-33) | 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 calendula officinalis - 12c hpus (promotes healthy skin and favorable scar tissue) silicea - 12c hpus (scars, keloids) the letters âhpusâ indicate that the components in this product are officially monographed in the homoeopathic pharmacopoeia of the united states
Product Elements:
H-scars formula calendula officinallis, silicea calendula officinalis flowering top calendula officinalis flowering top silicon dioxide silicon dioxide european hazelnut oil cymbopogon martini top daucus carota subsp. sativus seed helichrysum italicum flower lavandula angustifolia flowering top salvia officinalis whole jojoba oil
Indications and Usage:
Indications: helps to reduce scar tissue
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 a cotton swab or your finger and apply 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- scars formula homeopathic for external use only 039 11ml (0.37 fl. oz) amoils.com scars label