NDC 80977-101 Joy Skin And Body Premium Pain Relieving

Menthol

NDC Product Code 80977-101

NDC 80977-101-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Joy Skin And Body Premium Pain Relieving with NDC 80977-101 is a a human over the counter drug product labeled by Joy Organics Llc. The generic name of Joy Skin And Body Premium Pain Relieving is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Joy Organics 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.

Joy Skin And Body Premium Pain Relieving 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.

  • MENTHOL, UNSPECIFIED FORM 4 g/100mL

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.

  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • SWEET MARJORAM OIL (UNII: ICH7BE016E)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Joy Organics Llc
Labeler Code: 80977
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: 03-10-2021 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.

Joy Skin And Body Premium Pain Relieving Product Label Images

Joy Skin And Body Premium Pain Relieving 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

Menthol 4%

Purpose

External analgesic

Use

For the temporary relief of minor aches and pains of the muscles and joints associated with• arthritis • simple backache • sprains • strains • bruises

Warnings

Flammable: Keep away from fire or flameFor external use only.Do not use• on wounds or damaged skin.When using this product• avoid contact with the eyes. If contact occurs, rinse with water to remove• do not bandage tightlyStop 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 daysIf pregnant or breast-feeding, 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

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.• children under 2 years of age: consult a doctor.

Other Information

• protect this product from excessive heat and direct sun.• store at room temperature.

Inactive Ingredients

Calcium Gluconate, Camphor(Cinnamomum camphora) Oil (0.5%), Cetearyl Glucoside, Cetyl Alcohol, Glucono delta-lactone, Hemp (Cannabis sativa) Extract, Organic Aloe Vera Leaf Juice (0.02%), Organic Glycerin (3%), Organic Lavender(Lavandula angustifolia) Oil (0.1%), Organic Olive(Olea europaea) Oil (10%), Organic Peppermint(Mentha piperita) Oil (0.1%), Organic Rosemary(Rosmarinus officinalis) Oil (0.1%), Organic Sweet Marjoram(Origanum majorana) Oil (0.1%), Organic Wintergreen(Gaultheria procumbens) Oil (0.1%), Potassium Sorbate, Safflower (Carthamus tinctorius) Oleosomes Extract, Sodium Benzoate, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopherol, Water(Aqua), Xanthan Gum.

Questions? +1-833-569-7223

You may also report serious side effects to this phone number.Mon - Fri: 9 AM to 5 PM

* Please review the disclaimer below.