NDC 41250-043 Body
Menthol Powder Topical
NDC Product Code 41250-043
Proprietary Name: Body What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used as external analgesic
NDC Code Structure
- 41250 - Meijer Distribution, Inc
- 41250-043 - Body
NDC 41250-043-38
Package Description: 283 g in 1 BOTTLE
NDC Product Information
Body with NDC 41250-043 is a human over the counter drug product labeled by Meijer Distribution, Inc. The generic name of Body is menthol. The product's dosage form is powder and is administered via topical form.
Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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.
Body 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.
RxNorm Crosswalk
What is RxNorm?RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.
The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:
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.
- STARCH, CORN (UNII: O8232NY3SJ)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
- ZINC OXIDE (UNII: SOI2LOH54Z)
- GUM TALHA (UNII: H18F76G097)
- EUCALYPTOL (UNII: RV6J6604TK)
- METHYL SALICYLATE (UNII: LAV5U5022Y)
- SALICYLIC ACID (UNII: O414PZ4LPZ)
- THYMOL (UNII: 3J50XA376E)
- ZINC STEARATE (UNII: H92E6QA4FV)
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.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Meijer Distribution, Inc
Labeler Code: 41250
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: 11-15-1987 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: 12-31-2023 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".
* Please review the disclaimer below.
Body Product Label Images
Body 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
- Purpose
- Uses
- Warnings
- When Using This Product
- Stop Use And Ask A Doctor
- Keep Out Of Reach Of Children
- Directions
- Inactive Ingredients
- Disclaimers
- Adverse Reactions
Active Ingredient
Menthol 0.15%
Purpose
External analgesic
Uses
- For temporary relief of pan and itching due to:minor burnssunburnminor cutsscrapesinsect bitesminor skin irritationsrashes due to poison ivy, poison oak, poison sumac
Warnings
For external use only
When Using This Product
Avoid contact with the eyes
Stop Use And Ask A Doctor
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 year of age and older - apply to affected area not more than 3 to 4 times dailychildren under 2 years of age - do not use, consult a doctorfor best results dry skin thoroughly before applying
Inactive Ingredients
Zea mays (corn) starch. sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate
Disclaimers
This product is sold by weight, not by volume. Some settling may occur during handling and shipping
Adverse Reactions
DISTRIBUTED BYMEIJER DISTRIBUTION, INCGRAND RAPIDS, MI 49544www.meijer.com379.001/379AB
* Please review the disclaimer below.