NDC 30142-043 Gel Cooling Pain Relief

Menthol

NDC Product Code 30142-043

NDC 30142-043-18

Package Description: 74 mL in 1 BOTTLE, WITH APPLICATOR

NDC 30142-043-21

Package Description: 89 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Gel Cooling Pain Relief with NDC 30142-043 is a a human over the counter drug product labeled by Kroger. The generic name of Gel Cooling Pain Relief is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Kroger

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.

Gel Cooling 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 160 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CHAMOMILE (UNII: FGL3685T2X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • JUNIPER BERRY (UNII: O84B5194RL)
  • MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Kroger
Labeler Code: 30142
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: 02-15-2020 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.

Gel Cooling Pain Relief Product Label Images

Gel Cooling 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 Ingrident

Menthol 4%

Purpose

External analgesic

Use

  • For temporary relief from minor aches and pains of muscles & joints associated withsimple backachearthritisstrainsbruisessprains

Warnings

For external use onlyFlammable, keep away from fire or flame.

When Using This Product

  • Avoid contact with the eyesdo not apply to wounds or damaged skindo not bandage tightly

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms 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.

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a doctor

Other Information

Store in a cool dry place with lid closed tightly

Inactive Ingredients

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

Adverse Reactions Section

Biofreeze is a registered trademark of Biofreeze Performance Health, Cuyahoga Falls, OH Biofreeze Performance Heath is not affilated with The Kroger Co. or this product.DISTRIBUTED BYTHE KROGER CO.CINCINNATI, OHIO 415202QUALITY GUARANTEE800-632-6900www.kroger.com

* Please review the disclaimer below.