Better Nature Pain Relief Cream
Menthol, Capsaicin
Better Nature Pty Ltd
Human Otc Drug
NDC 73454-002Better Nature Pain Relief Cream also known as Menthol, Capsaicin is a human otc drug labeled by 'Better Nature Pty Ltd'. National Drug Code (NDC) number for Better Nature Pain Relief Cream is 73454-002. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Better Nature Pain Relief Cream drug includes Capsaicin - .25 mg/g Menthol - 12.5 mg/g . The currest status of Better Nature Pain Relief Cream drug is Active.
Drug Information:
| Drug NDC: | 73454-002 |
| 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: | Better Nature Pain Relief Cream |
| 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: | Menthol, Capsaicin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Better Nature Pty Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | CAPSAICIN - .25 mg/g
MENTHOL - 12.5 mg/g
|
| 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: | 02 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | Better Nature Pty Ltd
|
| 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. |
| UPC: | 9346630000210
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
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 |
|---|
| 73454-002-75 | 1 TUBE in 1 CARTON (73454-002-75) / 75 g in 1 TUBE | 02 Dec, 2019 | 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 menthol (1.25%).............topical analgesic capsicum oleoresin 0.0625%.........topical analgesic (containing capsaicin 0.025%)
Product Elements:
Better nature pain relief cream menthol, capsaicin lavender oil lecithin, soybean hypericum oil menthol menthol sorbitan olivate aloe vera leaf black pepper oil tricaprilin eucalyptus oil glyceryl caprylate glyceryl 1-undecylenate arnica montana flower cetearyl olivate glyceryl monostearate grapefruit oil jojoba oil capsaicin capsaicin cetostearyl alcohol glycerin orange oil water rosemary oil .alpha.-tocopherol acetate methyl salicylate
Indications and Usage:
Uses temporarily relieves minor pain associated with: arthritis simple backache strains sprains bruises
Warnings:
Warnings for external use only do not use if you are allergic to salicylates (including aspirin) unless directed by doctor skin is infected or damaged excessive irritation develops 12 years of age or under. when using this product use only as directed avoid contact with eyes or mucous membranes do not apply to wounds, damaged, broken or irritated skin do not bandage tightly or use a heating pad stop and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within days redness develops. if pregnant or breastfeeding, ask a healthcare professional before use. keep out of reach of children. if swallowed, contact a physician or contact a poison control center immediately.
Do Not Use:
Warnings for external use only do not use if you are allergic to salicylates (including aspirin) unless directed by doctor skin is infected or damaged excessive irritation develops 12 years of age or under. when using this product use only as directed avoid contact with eyes or mucous membranes do not apply to wounds, damaged, broken or irritated skin do not bandage tightly or use a heating pad stop and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within days redness develops. if pregnant or breastfeeding, ask a healthcare professional before use. keep out of reach of children. if swallowed, contact a physician or contact a poison control center immediately.
When Using:
When using this product use only as directed avoid contact with eyes or mucous membranes do not apply to wounds, damaged, broken or irritated skin do not bandage tightly or use a heating pad
Dosage and Administration:
Directions adults and children 13 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 13 years of age: consult a physician.
Stop Use:
Stop and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within days redness develops.
Package Label Principal Display Panel:
Better nature pain relief cream 100% naturally sourced with menthol & capsicum oleoresin regular australian made net wt. 2.64oz (75g) better nature 1 better nature 2
Further Questions:
Questions or comments? call toll free 1-800-720-5801 adverse event reporting contact 1-800-222-1222