Cold Therapy Gel
FDA Label NDC 68678-013

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 68678-013). 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 uses, active ingredient, purpose, directions, warnings, when using this product:, stop use and ask doctor if:, 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

Uses

Temporary relieves minor aches and pains associated with

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

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Directions

Adults and children 2 years and older: 

Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

Warnings

For external use only

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 ointment, creams, sprays or 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

Keep Out Of Reach Of Children

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

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:

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

If Pregnant Or Breast Feeding:

Consult a health professional before use

Pdp

CryoDerm
PAIN RELIEVING
COLD THERAPY ROLL-ON
Vanishing Scent . Natural Soothing Menthol
Essential Oils & Natural Extracts

Paraben Free / Propylene Glycol Free / Aspirin Free
NSAID Free / Silicone Dioxide Free / Gluten Free

Fast, Deep Penetrating Pain Relief for:
Muscle Strains, Joint Pain, Backache, Arthritis,
Sprained Ligaments & Bruises

Pain Relieving Gel . Greaseless . No-Mess . Non-Staining

3 fl.oz. 95mL

* Please review the disclaimer below.