Soothanol X2
FDA Label NDC 50972-766

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newmarket Health Products Llc for the product Soothanol X2 (NDC 50972-766). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, pregnancy, otc - 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

Otc - Active Ingredient

Active Ingredients

Capsaicin 0.20%

Menthol 12%

Otc - Purpose

Purpose

Topical Analgesic

Topical Analgesic

Indications & Usage

Uses for temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings

For external use only.

Otc - When Using

When using this product

  • avoid contact with eyes or mucus membranes
  • do not bandage tighly
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask doctor if

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

Pregnancy

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

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

Other information

Store in a cool, dry place.

Dosage & Administration

Directions

  • adults and children 12 years of age and older: wash hands and affected area with lukewarm water and apply 2-3 drops with fingertips not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • do not use otherwise than as directed

Inactive Ingredient

Inactive ingredients

arnica flower, calendula flower, dimethyl sulfoxide (DMSO), d-Limonene oil, emu oil (non-vegetarian), extra virgin olive oil, ginger root, methylsulfonylmethane (MSM), st. john's wort, wintergreen oil

Package Label.Principal Display Panel

North Star 

Nutritionals 

SOOTHANOL X2 

Pain Relieving Drops 

Net: 1 Fluid OZ/ 30 ML

Soothanolx2 (Soothanolx2image)

Soothanolx2 (Soothanolx2image)

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