Theraworx Pain Relief Roll-on With Lidocaine For Diabetics Liquid
FDA Label NDC 61594-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avadim Holdings, Inc. for the product Theraworx Pain Relief Roll-on With Lidocaine For Diabetics (NDC 61594-030). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4.00%

Purpose

Topical analgesic

Uses

For temporary relief of pain

Warnings

For external use only.

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas.

When Using This Product

avoid contact with the eyes.

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.

If Pregnant Or Breastfeeding,

ask a health professional before use.

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: 
  • shake bottle well 
  • roll a thin layer to each affected area and allow to air dry 
  • repeat 
  • Wash hands after applying product 
  • do not use more than 3 to 4 times daily 
  • children under 2 years of age do not use: consult a doctor

Other Information

Store between 32°F and 120°F

Inactive Ingredients (Alphabetical)

Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract

Package Labeling:

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