NDC 63868-692 Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength

Camphor, Menthol, Methyl Salicylate

NDC Product Code 63868-692

NDC CODE: 63868-692

Proprietary Name: Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Camphor, Menthol, Methyl Salicylate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-692 - Quality Choice Ultra Strength Pain Relieving Cream

NDC 63868-692-04

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength with NDC 63868-692 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength is camphor, menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

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.

Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength 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 (NATURAL) 40 mg/g
  • MENTHOL, UNSPECIFIED FORM 100 mg/g
  • METHYL SALICYLATE 300 mg/g

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.

  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
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: 03-01-2021 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.

Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength Product Label Images

Quality Choice Ultra Strength Pain Relieving Cream Ultra Strength 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 4%Menthol 10%Methyl salicylate 30%

Purpose

Camphor - Topical analgesicMenthol - Topical analgesicMethyl salicylate - Topical analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated with:simple backachearthritisstrainssprainsbruises

Warnings

For external use only

Do Not Use

  • On wounds or damaged skinwith a healing padon a child under 12 years of age with arthritis-like conditions

Ask A Doctor Before Use If You Have

Redness over the affected area

When Using This Product

  • Use only as directedavoid contact with eyes or mucous membranesdo not bandage tightly

Stop Use And Ask A Doctor If

  • Skin redness or excessive irritation of the skin occurscondition worsenssymptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

  • Adults and children 12 years and over; apply to affected area not more than 3 to 4 times dailychildren under 12 years of age; consult a physician

Other Information

  • Store at 20-25 C (68-77F)do not use if tube seal under cap is broken

Inactive Ingredients

Carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

* Please review the disclaimer below.