Cold Therapy Spray
FDA Label NDC 68678-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ahc Ventures Corp Dba Cryoderm for the product Cold Therapy (NDC 68678-012). 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 stop use and ask doctor if:, inactive ingredients, if pregnant or breast feeding, when using this product, active ingredient, uses, purpose, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Stop Use And Ask Doctor If:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritatio develops

Inactive Ingredients

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

If Pregnant Or Breast Feeding

Ask a healthcare professional before use

When Using This Product

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointmen

Active Ingredient

Menthol USP 10.0%

Uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Purpose

Pain Reliever   

Warnings

For external use only

Keep Out Of Reach Of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

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