NDC 41250-356 Meijer Pain Relieving Balm Analgesic

Trolamine Salicylate

NDC Product Code 41250-356

NDC 41250-356-01

Package Description: 113 g in 1 JAR

NDC Product Information

Meijer Pain Relieving Balm Analgesic with NDC 41250-356 is a a human over the counter drug product labeled by Meijer Distribution, Inc. The generic name of Meijer Pain Relieving Balm Analgesic is trolamine salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Meijer Distribution, 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.

Meijer Pain Relieving Balm Analgesic 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.

  • TROLAMINE SALICYLATE 10 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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TAMANU OIL (UNII: JT3LVK84A1)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TURMERIC (UNII: 856YO1Z64F)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • MACADAMIA OIL (UNII: 515610SU8C)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • 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.
  • 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: Meijer Distribution, Inc
Labeler Code: 41250
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: 04-30-2020 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: 12-31-2021 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.

Meijer Pain Relieving Balm Analgesic Product Label Images

Meijer Pain Relieving Balm Analgesic 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

Other

Drug Facts

  • Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.Avoid contact with eyesDo not apply to wounds or damaged skinDo not bandage tightlyDo not use with heating pads or heating devicesIf condition worsens, or if the symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544

Active Ingredient

Trolamine Salicylate 10%

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.

Otc - Pregnancy Or Breast Feeding

If 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 6 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do Not Use.

Other Information

Store at room temperature

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, arnica montana flower extract, boswellia carterii oil, butyrospermum parkii (shea) butter, calophyllum inophyllum seed oil, caprylic/capric triglyceride, cetyl alcohol, curcuma longa (turmeric) root extract, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, harpagophytum procumbens root extract, isopropyl palmitate, macadamia ternifolia seed oil, menthol, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, propylene glycol, salix alba (willow) bark extract, sodium hyaluronate, sodium hydroxide, sodium PCA, stearic acid, theobroma cacao (cocoa) seed butter, water.

* Please review the disclaimer below.