Debbies Down And Dirty Deep Tissue Joint And Muscle Cream
FDA Label NDC 71523-833

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dd&d Manufacturing Co., Ltd for the product Debbies Down And Dirty Deep Tissue Joint And Muscle (NDC 71523-833). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not apply, ask a physician before use if, when using this product, stop use and ask a physician if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 10%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Warnings

For external use only

Do Not Apply

to wounds or damaged skin.

Ask A Physician Before Use If

you have redness over the affected area.

When Using This Product

  • avoid contact with the eyes.
  • do not bandage.

Stop Use And Ask A Physician If

  • condition worsens  or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs.

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, Xanthan Gum.

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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