Xoten-c
FDA Label NDC 64038-944

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Living Well Pharmacy Inc. for the product Xoten-c (NDC 64038-944). 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, use, warnings, do not use, stop use and ask a doctor if, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Methyl salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • sprains
  • strains
  • bruises

Warnings

For external use only.

Do Not Use

  • on wounds
  • damaged, broken, or irritated skin
  • with a heating pad
  • immediately before or after taking a bath or shower

Stop Use And Ask A Doctor If

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

When Using This Product

  • avoid contact with lips, eyes, nose and any mucous membranes at all times
  • do not bandage tightly

Keep Out Of Reach Of Children.

If swallowed get medical help or contact Poison Control Center right away.

Directions

  • use only as directed
  • Wash hands thoroughly after use to avoid spreading lotion to the eyes or other sensitive areas of the body
  • if applying lotion to the hands, wait 30 minutes before washing hands
  • Adults and children 12 years of age and older:
    • apply to affected area not more than 3-4 times daily
    • Children under 12 years of age:
      • do not use
      • consult a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

D.I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Arnica Extract, Aloe Babadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutaronitrile

Principal Display Panel – Bottle Label

64038-094401

XOTEN-C

Pain Relief
Lotion

Beneficial for relieving
muscle pain and swelling

Manufactured for: Net Wt. 4 oz
MedChem Manufacturing (113.4 g)
Torrance, CA 90501

Principal Display Panel – Bottle Label (Xot00 0000 01)

Principal Display Panel – Bottle Label (Xot00 0000 01)

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