NDC 72351-641 Pain Relief Cold Therapy Gel 3 Fl Oz

Menthol 4% Gel

NDC Product Code 72351-641

NDC CODE: 72351-641

Proprietary Name: Pain Relief Cold Therapy Gel 3 Fl Oz 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: Menthol 4% Gel 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.

Product Characteristics

Color(s):
GREEN (C48329)

NDC Code Structure

  • 72351 - Sotac Pharmaceutical Private Limited
    • 72351-641 - Pain Relief Cold Therapy Gel 3 Fl Oz

NDC 72351-641-03

Package Description: 88.72 mL in 1 TUBE

NDC Product Information

Pain Relief Cold Therapy Gel 3 Fl Oz with NDC 72351-641 is a a human over the counter drug product labeled by Sotac Pharmaceutical Private Limited. The generic name of Pain Relief Cold Therapy Gel 3 Fl Oz is menthol 4% gel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Sotac Pharmaceutical Private Limited

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Pain Relief Cold Therapy Gel 3 Fl Oz 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 40 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CARBOMER 934 (UNII: Z135WT9208)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • BRILLIANT BLUE G (UNII: M1ZRX790SI)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SORBIC ACID (UNII: X045WJ989B)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)

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: Sotac Pharmaceutical Private Limited
Labeler Code: 72351
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: 04-01-2021 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.

Pain Relief Cold Therapy Gel 3 Fl Oz Product Label Images

Pain Relief Cold Therapy Gel 3 Fl Oz 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

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and

joints associated with •arthritis •backache •strains •sprains

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Ask A Doctor Before Use If You Have

Sensitive skin

When Using This Product

• avoid contact with the eyes or mucous membranes• do not apply to wounds or damaged skin• do not use with other ointments, creams, sprays or liniments• do not apply to irritated skin or if excessive irritation develops• do not bandage• wash hands after use with cool water• do not use with heating pad or device

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If Pregnant Or Breast-Feeding

Ask a health professional before use

Keep Out Of Reach Of Children.

If accidentally ingested, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

Directions


Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary

Children under 2 years of age: consult physician

Other Information

• store in a cool dry place

Inactive Ingredients

Aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

* Please review the disclaimer below.