Crampy Belly Rub
Camphor
Little Moon Essentials
Human Otc Drug
NDC 70722-260Crampy Belly Rub also known as Camphor is a human otc drug labeled by 'Little Moon Essentials'. National Drug Code (NDC) number for Crampy Belly Rub is 70722-260. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Crampy Belly Rub drug includes Camphor (natural) - 1.1 g/100g . The currest status of Crampy Belly Rub drug is Active.
Drug Information:
| Drug NDC: | 70722-260 |
| 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: | Crampy Belly Rub |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Little Moon Essentials |
| 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: | CAMPHOR (NATURAL) - 1.1 g/100g
|
| 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: | 28 Sep, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | Little Moon Essentials
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1811772
|
| 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
|
| 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 |
|---|
| 70722-260-02 | 56.7 g in 1 BOTTLE (70722-260-02) | 28 Sep, 2016 | 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:
Uses temporarily relieves minor pain associated with simple backache âmuscle strains sprains âbruises
Product Elements:
Crampy belly rub camphor sesame oil castor oil methyl salicylate lavender oil cinnamon oil bergamot oil ginger oil arnica montana geranium oil, algerian type clary sage oil spearmint oil hypericum perforatum calendula officinalis flower olive oil camphor (natural) camphor (natural)
Indications and Usage:
âdirections adults and children over 112 years: â apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin ârepeat as necessary, but no more 3 to 4 times daily, allowing a minimum of 2-3 hours between applications after applying, wash hand with soap and water children 12 years or younger: ask a doctor
Warnings:
Warning for external use only when using this product use only as directed read and follow all directions and warnings on this label rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) or medicated patches to teha area of use âavoid contact with eyes or mucous membranes âdo not apply wounds or damaged, broken or irritated skin âa trasient burning sensation may occur upon applications but generally dissapears in several days
Dosage and Administration:
Purpose topical analgesic
Stop Use:
Stop use and ask a doctor âcondition worsens redness is present irritation develops symptoms persist for more 7 days or clear up and occur agin within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Package Label Principal Display Panel:
Principle display panel - 2 oz bottle 2oz crampy belly rub