NDC 70722-260 Crampy Belly Rub

Camphor

NDC Product Code 70722-260

NDC 70722-260-02

Package Description: 56.7 g in 1 BOTTLE

NDC 70722-260-04

Package Description: 113.4 g in 1 BOTTLE

NDC Product Information

Crampy Belly Rub with NDC 70722-260 is a a human over the counter drug product labeled by Little Moon Essentials. The generic name of Crampy Belly Rub is camphor. The product's dosage form is oil and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1811772.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Crampy Belly Rub Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SESAME OIL (UNII: QX10HYY4QV)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • CLARY SAGE OIL (UNII: 87L0D4U3M0)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • OLIVE OIL (UNII: 6UYK2W1W1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Little Moon Essentials
Labeler Code: 70722
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-28-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Crampy Belly Rub Product Label Images

Crampy Belly Rub Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Camphor 1.1%

Purpose

Topical Analgesic

Uses

  • Temporarily relieves minor pain associated withSimple backache​Muscle strainsSprains​Bruises

Warning

  • For external use onlyWhen using this product Use only as directedRead and follow all directions and warnings on this labelRare cases of serious burns have been reported with products of this typeDo not bandage tightly or apply local heat (such as heating pads) or medicated patches to teha area of use​Avoid contact with eyes or mucous membranes​Do not apply wounds or damaged, broken or irritated skin​A trasient burning sensation may occur upon applications but generally dissapears in several days

Stop Use And Ask A Doctor

  • ​Condition worsensRedness is presentIrritation developsSymptoms persist for more 7 days or clear up and occur agin within a few daysYou experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding

Ask a health professional before use

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • Adults and children over 112 years:​Apply a thin layer to affected area
  • Massage into painful area until thoroughly absorbed into skin​Repeat as necessary, but no more 3 to 4 times daily, allowing a minimum of 2-3 hours between applicationsAFTER APPLYING, WASH HAND WITH SOAP AND WATERchildren 12 years or younger: ask a doctor

Other Information

Store at 68-77º​F (20-25ºC)Protect from excessive moisture

Inactive Ingredients

Organic Sesame oil( Sesamum indicum)Organic Olive oil ( Olea Europaea)Castor oil (Ricinus communis)Wintergreen oil (Gaultheria procumbens)Lavender oil (Lavendula angustifolia)Cinnamon oil (Cinnamomum zeylanicum)Geranium oil (Pelargonium graveolens)Bergamot oil (Citrus bergamia)Clary sage oil ( Salvia sclarea)Spearmint oil (Mentha spicata)Ginger powder (Zingiber officinale)Arnica (Arnica Montana)st. john¹​s wort (Hypericum perforatum)Calendua (Calendula officinalis)

* Please review the disclaimer below.