NDC 60717-218 Medterra Pain Cream 500
Menthol
NDC Product Code 60717-218
Proprietary Name: Medterra Pain Cream 500 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.
NDC Code Structure
- 60717 - Rna Pharma, Llc
- 60717-218 - Medterra Pain Cream 500
NDC 60717-218-50
Package Description: 1 CREAM in 1 BOTTLE, PUMP
NDC Product Information
Medterra Pain Cream 500 with NDC 60717-218 is a a human over the counter drug product labeled by Rna Pharma, Llc. The generic name of Medterra Pain Cream 500 is menthol. The product's dosage form is cream and is administered via topical form.
Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Medterra Pain Cream 500 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.
- CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
- GLYCERIN (UNII: PDC6A3C0OX)
- ROSEMARY (UNII: IJ67X351P9)
- TOCOPHEROL (UNII: R0ZB2556P8)
- ARGAN OIL (UNII: 4V59G5UW9X)
- CETEARYL OLIVATE (UNII: 58B69Q84JO)
- ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
- PEPPERMINT OIL (UNII: AV092KU4JH)
- GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
- SHEA BUTTER (UNII: K49155WL9Y)
- HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
- COCONUT OIL (UNII: Q9L0O73W7L)
- MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
- CAPRYLYL GLYCOL (UNII: 00YIU5438U)
- RICE BRAN (UNII: R60QEP13IC)
- BENTONITE (UNII: A3N5ZCN45C)
- CANNABIDIOL (UNII: 19GBJ60SN5)
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- JOJOBA OIL (UNII: 724GKU717M)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- XANTHAN GUM (UNII: TTV12P4NEE)
- SORBITAN OLIVATE (UNII: MDL271E3GR)
- WATER (UNII: 059QF0KO0R)
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: Rna Pharma, Llc
Labeler Code: 60717
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: 02-11-2021 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: 12-31-2022 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 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. Values = ‘Y’ or ‘N’.
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