NDC 73371-048 Clean Remedies Cr Pain Relief

Menthol

NDC Product Code 73371-048

NDC 73371-048-03

Package Description: 85 g in 1 TUBE

NDC Product Information

Clean Remedies Cr Pain Relief with NDC 73371-048 is a a human over the counter drug product labeled by Clean Remedies, Llc. The generic name of Clean Remedies Cr Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clean Remedies, Llc

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.

Clean Remedies Cr 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 20 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • BROMELAINS (UNII: U182GP2CF3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PAPAIN (UNII: A236A06Y32)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCOA (UNII: D9108TZ9KG)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARAMEL (UNII: T9D99G2B1R)

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: Clean Remedies, Llc
Labeler Code: 73371
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: 09-10-2019 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.

Clean Remedies Cr Pain Relief Product Label Images

Clean Remedies Cr 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 Ingredient:

Menthol 2.00%

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated 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 physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bromelain, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum) Hemp Extract, Carthamus Tinctorius (Safflower) Oil, Cetearyl Alcohol, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Oil, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Melia Azadirachta (Neem) Oil, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM) Papain, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Salix Nigra (Willow) Bark Extract, SD-Alcohol 40B, Stearic Acid, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Caramel Color.


*Denotes cerified organic ingredient.

* Please review the disclaimer below.