NDC 47682-321 Pain Relief

Analgesic Menthol

NDC Product Code 47682-321

NDC Product Information

Pain Relief with NDC 47682-321 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Pain Relief is analgesic menthol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Pain Relief Active Ingredient(s)

Additional informationCallout TooltipWhat 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 70 mg/L

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Unifirst First Aid Corporation
Labeler Code: 47682
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Pain Relief Product Label Images

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 Ingredients

USP Menthol 7%

Purpose

Topical analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only. Flammable. Keep away from flame.

Do Not Use

  • On open wounds or damaged skin

Ask A Doctor Before Use If

  • You are prone to allergic reactions to salicylates, including aspirin

When Using This Product

  • Avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 days or clear up and recur again within a few daysexcessive skin irritation occurs

If Pregnant Or Breast Feeding,

Ask a doctor before use.

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 and older):Shake well and aply to affected araea not more than 3-4 times daily.Do not bandage tightly.Children under 2 years:Consult a doctor

Other Information

  • Store at room temperature 56°-86°F (15°-30°C)will not stain clothing

Inactive Ingredients

Coconut oil, eucalyptus lkeaf oil, glycerol, isopropyl alcohol, peppermint oil, water, wintergreen leaf oil

Green Guard Pain Relief Spray Label

Pain Relief sprayFast Acting pain ReliefFor Temporary Relief of Minor Aches and PainsGreen Guard®2 Fl. Oz. (59.1 mL)

* Please review the disclaimer below.

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