NDC 72246-112 Dr. Ds Super 7 Pain Relief

Menthyl Salicylate And Menthol

NDC Product Code 72246-112

NDC 72246-112-01

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 88 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Dr. Ds Super 7 Pain Relief with NDC 72246-112 is a a human over the counter drug product labeled by Promedx Innovations Inc. The generic name of Dr. Ds Super 7 Pain Relief is menthyl salicylate and menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Promedx Innovations Inc

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.

Dr. Ds Super 7 Pain Relief 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 20 mg/mL
  • MENTHYL SALICYLATE, (+/-)- 100 mg/mL

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ROSEMARY (UNII: IJ67X351P9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FLAX SEED (UNII: 4110YT348C)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Promedx Innovations Inc
Labeler Code: 72246
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: 09-04-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Dr. Ds Super 7 Pain Relief 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

Menthyl Salicylate 10%Menthol 2%

Purpose

Topical analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated withsimple backachearthritisstrains and sprainsbruises

Warnings

For external use only

Allergy Alert

  • Do not use if you are allergic to plants of the Asteraceae / Compositae / Daisy family

When Using This Product

  • Avoid contact with the eyes and mucous membranesdo not apply to wounds or damaged skindo not bandage tightlydo not apply with external heat, such as an electric pad, as this may result in excessive skin irritation or skin burn

Ask A Healthcare Professional Before Use If You Are

  • Taking anticoagulant medications

Stop Using And Ask A Healthcare Professional If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few daysif a rash develops, or you become hypersensitive and/or burning, blistering or swelling occurs, discontinue use and seek medical help immediately

If Pregnant Or Breast-Feeding

  • Ask a healthcare professional before use

Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 years of age and older:shake bottle before useapply a thin and even coat to affected area not more than 3 to 4 times dailyrub and/or massage into skin until the preparation disappearsChildren (2 to 12 years old)ask a doctorapplication should be supervised by an adult

Other Information

  • Store at room temperature 15°C - 30°C (59°F - 86°F)do not use if quality seal is missing or brokenstore in airtight, light-resistant container

Inactive Ingredients

Arnica Montana Flower Extract, Benzoic Acid, Brassica Campestris (Rapeseed) Seed Oil, Citric Acid, Dehydroacetic Acid, Eucalyptus Globulus Leaf Essential Oil, Glycerin, Linum Usitatissimum (Linseed) Seed Extract, MSM, Myristyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Peppermint Oil (Mentha piperita), Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Stearoyl Glutamate, Water, Xanthan Gum

* Please review the disclaimer below.