Protec Pain Relief Cold Therapy
FDA Label NDC 68678-065

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 for the product Protec Pain Relief Cold Therapy (NDC 68678-065). 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 ingredient, purpose, uses:, warnings:, when using this product:, stop use and ask doctor if:, if pregnant or breast feeding, 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 Ingredient

Menthol USP 8.0%

Purpose

Pain Reliever

Uses:

Temporary relieves minor aches and pains associated with

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

Warnings:

For external use only

When Using This Product:

  • Use only as directed
  • Do not bandage or use a heating pd or device
  • Avoid contact with eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not use with other ointments, creams, sprays, liniments
  • After applying wash hands thoroughly with cool water

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 irritation develops

If Pregnant Or Breast Feeding

Ask a health professional before use

Keep Out Of Reach Of Children:

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

Directions:

Adults and children 2 years of age and older: Spray directly onto affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more the 4 times daily
Children under 2 years of age: Consult a Physician

Other Information:

Store in a cool dry place with lid or cap closed tightly.
Flammable: Keep away from excessive heat or open flame

Inactive Ingredients

Ilex Paraguariensis Leaf Extract, Arnica, Boswellia Serrata, Eucalyptus Oil, Peppermint Oil, Hyaluronic Acid, Yucca Extract, Nitric Oxide, Dimethyl Sulfone, Citric Acid, SD Alcohol 39 C, Purified Water

* Please review the disclaimer below.