NDC 73334-155 Dr Greenes Good Stuff Pain Relief Roll On

Menthol

NDC Product Code 73334-155

NDC 73334-155-03

Package Description: 88.7 mL in 1 BOTTLE

NDC Product Information

Dr Greenes Good Stuff Pain Relief Roll On with NDC 73334-155 is a a human over the counter drug product labeled by Dr. Greene's Good Stuff, Llc. The generic name of Dr Greenes Good Stuff Pain Relief Roll On is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Dr. Greene's Good Stuff, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Dr Greenes Good Stuff Pain Relief Roll On 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 30 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)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Dr. Greene's Good Stuff, Llc
Labeler Code: 73334
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: 09-01-2019 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.

Dr Greenes Good Stuff Pain Relief Roll On Product Label Images

Dr Greenes Good Stuff Pain Relief Roll On 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 3.00%

Indications

For the temporary relief of minor aches and pains of the muscles and joints asscoated with arthritis, simple backache, sprains, bruises, and strains.

Warnings

- For external use only.- Avoid contact with eyes.- If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

- If swallowed, consult physician.- Do not apply to wounds or damaged skin.- Do not bandage tightly.

If Pregnant Or Breast Feeding,

Contact physician prior to use.

Directions

- Adults and children two-years of age or older. Apply to affected area not more than three to four times daily.- Children under two-years of age consult a physican.

Additional Information

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum Hemp) Oil, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Xanthan Gum.

* Please review the disclaimer below.