NDC 73454-003 Better Nature Pain Relief Sport Gel


NDC Product Code 73454-003

NDC 73454-003-75

Package Description: 1 TUBE in 1 CARTON > 75 g in 1 TUBE

NDC Product Information

Better Nature Pain Relief Sport Gel with NDC 73454-003 is a a human over the counter drug product labeled by Better Nature Pty Ltd. The generic name of Better Nature Pain Relief Sport Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Better Nature Pty Ltd

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.

Better Nature Pain Relief Sport Gel 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • AGAR (UNII: 89T13OHQ2B)
  • ALCOHOL (UNII: 3K9958V90M)

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: Better Nature Pty Ltd
Labeler Code: 73454
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: 12-02-2019 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: 12-31-2020 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.

Better Nature Pain Relief Sport Gel 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

Menthol (5.00%)


Menthol (5.00%)................Topical Analgesic


  • Temporarily relieves minor pain associated with:arthritissimple backachestrainssprainsbruises


For external use only

Otc - Do Not Use

  • Do not use ifyou are allergic to salicylates (including aspirin) unless directed by doctorskin is infected or damagedexcessive irritation develops12 years of age or under.

Otc - When Using

  • When using this productuse only as directedavoid contact with eyes or mucous membranesdo not apply to wounds, damaged, broken or irritated skindo not bandage tightly or use a heating padApply kinezio tape only when skin is completely dry.

Otc - Stop Use

  • Stop and ask doctor ifcondition worsenssymptoms persist for more than 7 days or clear up and occur again within daysredness develops.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, contact a physician or contact a Poison Control Center immediately.


  • Adults and children 13 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Children under 13 years of age: consult a physician.

Other Information

  • Store between 15C (59F) and 30C(86F) with the cap closedNotice: Colour may vary.

Inactive Ingredients

Agar, arnica oil, eucalyptus oil, ethanol, glycerin, glyceryl caprylate, glyceryl undecylenate, lecithin, purified water, pullulan, rosemary oil, sclerotium gum, spirulina powder, wintergreen oil and xanthan gum.

Better Nature

Better NaturePain Relief Sport Gel100% Naturally SourcedWith MentholCOOLINGAustralian MadeNet Wt. 2.64oz (75g)

* Please review the disclaimer below.