NDC 72927-976 Jointflex

Camphor

NDC Product Code 72927-976

NDC 72927-976-02

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 99 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Jointflex with NDC 72927-976 is a a human over the counter drug product labeled by Strides Consumer Llc. The generic name of Jointflex is camphor. The product's dosage form is cream and is administered via topical form.

Labeler Name: Strides Consumer Llc

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.

Jointflex 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.

  • CAMPHOR (SYNTHETIC) 3.2 g/100g

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.

  • ACETYLATED LANOLIN (UNII: 2X654GD19H)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROXYLATED LANOLIN (UNII: EOI0B9800C)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • SHARK CARTILAGE (UNII: D2YCN1I522)
  • 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: Strides Consumer Llc
Labeler Code: 72927
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: 06-01-2021 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.

Jointflex 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 (3.2%)

Purpose

Topical analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Warnings

For external use only.

Do Not Use

  • If skin is irritated or damagedexcessive irritation develops12 years of age or under

Ask A Doctor Befor Use If You Have

  • Redness over the affected area

When Using This Product

  • Use only as directedavoid contact with the eyes and mucous membranesdo not apply to wounds, damaged, broken or irritated skindo not bandage tightly or use a heating paddo not swallow

Stop Use And Ask Doctor If

  • Condition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysredness develops

Keep Out Of Reach Of Children

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

Directions

  • Rotate the massager head to ON position and squeeze tube gently to dispense. Return the massager head to OFF position. Using a circular pattern, gently massage over the pain inflicted area using the built-in roller balls until the Emulsion Gel disappears. adults and children 12 years of age and older:clean, rinse and dry skin prior to applicationapply generously to painful muscles and joints, gently massaging until the JoinFlex® Pain Relieving Cream disappearsrepeat as necessary, but no more than 4 times a dayfor optimum benefit, use daily for at least two weeks and continue to use daily thereafter children under 12 years of age:ask a doctor

Other Information

  • Store at room temperature with the cap closednotice: because this product contains natural ingredients, color may vary

Inactive Ingredients

Acetylated Lanolin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Dimethiconol Stearate, Disodium EDTA, dl Panthenol, Fragrance, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropyl Methycellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

* Please review the disclaimer below.