Extra Strength Hua Tuo Pain Relief
Camphor And Menthol
Madison One Acme Inc
Human Otc Drug
NDC 55614-630Extra Strength Hua Tuo Pain Relief also known as Camphor And Menthol is a human otc drug labeled by 'Madison One Acme Inc'. National Drug Code (NDC) number for Extra Strength Hua Tuo Pain Relief is 55614-630. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Extra Strength Hua Tuo Pain Relief drug includes Camphor (synthetic) - 3.1 g/100g Menthol - 2.6 g/100g . The currest status of Extra Strength Hua Tuo Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 55614-630 |
| 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: | Extra Strength Hua Tuo Pain Relief |
| 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: | Madison One Acme Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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 (SYNTHETIC) - 3.1 g/100g
MENTHOL - 2.6 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TRANSDERMAL
|
| 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: | 01 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 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: | MADISON ONE ACME INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2118540
|
| 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: | 5TJD82A1ET
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 |
|---|
| 55614-630-01 | 1 POUCH in 1 BOX (55614-630-01) / 6 PATCH in 1 POUCH / 1 g in 1 PATCH | 01 Apr, 2020 | 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 external analgesic external analgesic
Product Elements:
Extra strength hua tuo pain relief camphor and menthol camphor (synthetic) camphor (synthetic) menthol menthol ocimum gratissimum leaf oil butylated hydroxytoluene cinnamon oil saposhnikovia divaricata root angelica dahurica root ginger lanolin natural latex rubber petrolatum rosin safflower nepeta tenuifolia flowering top zinc oxide
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints due to: â simple backache â arthritis â strains â bruises â sprains
Warnings:
Warnings for external use only allergy alert: this product contains natural rubber latex which may cause allergic reactions.
Do Not Use:
Warnings for external use only allergy alert: this product contains natural rubber latex which may cause allergic reactions.
When Using:
When using this product â avoid contact with the eyes or mucous membranes â do not bandage tightly â do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns) â avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch
Dosage and Administration:
Directions â adults and children 2 years of age and older: remove the protective film from the patch. apply to affected area not more than 3 to 4 times daily. â children under 2 years of age: consult your physician
Stop Use:
Stop use and ask a doctor if â condition worsens â symptoms persist for more than 7 days â symptoms clear up and occur again within a few days â excessive irritation of the skin develops â nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs â you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) â when using for pain of arthritis: â pain persists for more than 10 days â redness is present â in conditions affecting children under 12 years of age
Adverse Reactions:
Report any unexpected side effects from the use of this product to the fda medwatch program.
Package Label Principal Display Panel:
Extra strength hua tuo pain relief patch ndc 55614-630-01 an effective herbal patch for the relief of aches and pains from muscles, strains, arthritis, backache, joints, bruises, sprains. 6 patches each patch 7 x 10 cm (2.75 x 4 in) apply for 12 hours box-01.jpg
Further Questions:
Questions or comments? (888) 221-3496 m-f 9 am to 5 pm â you may also report serious side effects to this phone number