NDC 76348-681 Op6 Menthol Warming Pain Cream

Menthol

NDC Product Code 76348-681

NDC 76348-681-01

Package Description: 1 JAR in 1 BOX > 112 g in 1 JAR (76348-681-04)

NDC Product Information

Op6 Menthol Warming Pain Cream with NDC 76348-681 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Op6 Menthol Warming Pain Cream 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.

Op6 Menthol Warming Pain Cream 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.

  • TABASCO PEPPER (UNII: J1M3NA843L)
  • .BETA.-PINENE (UNII: 4MS8VHZ1HJ)
  • HUMULENE (UNII: 54W56MD2WD)
  • TERPINOLENE (UNII: N9830X5KSL)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • VALENCENE (UNII: 96H21P91IG)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
  • CORN OIL (UNII: 8470G57WFM)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GRAPEFRUIT OIL (UNII: YR377U58W9)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • LAURETH-7 (UNII: Z95S6G8201)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • MYRCENE (UNII: 3M39CZS25B)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CARYOPHYLLENE (UNII: BHW853AU9H)
  • .ALPHA.-PINENE (UNII: JPF3YI7O34)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 09-14-2021 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 - 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.

Op6 Menthol Warming Pain Cream 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

Otc - Active Ingredient

Menthol 5 percent

Warnings

For external use onlyWhen using this product do not bandage tightly
avoid contact with eyedo not apply to wounds or damaged skinStop use and ask doctorif condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few daysKeep out of reach of childrenIf swallowed get medical help or contact Poison Control Center right away

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away.

Otc - Purpose

Topical Analgesic

Dosage & Administration

Directionsadults and children 12 years of age and olderapply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary

Inactive Ingredient

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract and proprietary terpene blend (Myrcene, b-Caryophyllene, d-Limonene, Humulene, Terpinolene, a-Pinene, Linalool, b-Pinene, Valencene, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid

Uses

For temporary relief of minor aches and pains asssociated witharthritissimple backachemuscle strainssprainsbruises

Recent Major Changes

SIMPLE DATE CHANGENothing considered as major

* Please review the disclaimer below.