NDC 82026-609 Pluscbd Pain Cream (muscle) 4oz

Camphor, Menthol

NDC Product Code 82026-609

NDC 82026-609-57

Package Description: 1 TUBE in 1 CARTON > 113.4 g in 1 TUBE

NDC Product Information

Pluscbd Pain Cream (muscle) 4oz with NDC 82026-609 is a a human over the counter drug product labeled by Cv Sciences, Inc.. The generic name of Pluscbd Pain Cream (muscle) 4oz is camphor, 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.

Pluscbd Pain Cream (muscle) 4oz 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • COMFREY (UNII: D05HXK6R3G)

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: Cv Sciences, Inc.
Labeler Code: 82026
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: 08-23-2021 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.

Pluscbd Pain Cream (muscle) 4oz Product Label Images

Pluscbd Pain Cream (muscle) 4oz 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 Ingredients

Camphor 5%Menthol 4%

Purpose

Camphor 5%.........................Topical AnalgesicMenthol 4%..........................Topical Analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated with:strainsarthritisbruisessprainssimple backache

Warnings

For external use only.

Otc - Do Not Use

  • Do not useon wounds or damaged skinon irritated skin

Otc - When Using

  • When using this productavoid contact with the eyes and mucous membranesdo not bandage tightly or use with a heating pad

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysyou experience swelling or blistering of the skin

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

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.

Directions

  • Apply thin layer and gently massage until it disappearsafter applying, wash hands with soap and wateradults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 12 years of age: consult a physician

Other Information

Store in cool dry place, away from direct sunlight

Inactive Ingredients

Water, isopropyl alcohol, glycerin, cetearyl olivate, sorbitan olivate, cannabidiol, phenoxyethanol, aloe barbadensis leaf juice, xanthan gum, isopropyl myristate, lysolecithin, sclerotium gum, pullulan, arnica montana extract, calendula officinalis flower extract, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, salix alba (willow) bark extract, symphytum officinale (comfrey) extract, citric acid

Questions?

855-758-7223

* Please review the disclaimer below.