Healthwise Cold Therapy Menthol Pain Relief Spray
FDA Label NDC 71101-985

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Cold Therapy Menthol Pain Relief (NDC 71101-985). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a 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

Drug Facts

Active Ingredient

Menthol 10.5%

Purpose

Pain relieving spray

Uses

Uses For the temporary relief of minor pain associated with • arthritis • simple backache • strains • sprains • bruises

Warnings

For external use only.

Flammable.Do not use while smoking or near heat or flame.  Donot use while smoking.  Do not punture or incinirate.  Contents under pressure.

When Using This Product

When using this product

• avoid contact with eyes

• do not apply to wounds or damage skin

• do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur withing a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

  • Adults and children 2 years or older:Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age:do not use , ask a doctor.

Other Information

Store out of direct sunlight, in a cool dry, well-ventilated area.  Do not store at temperature above 120F (49C)

Inactive Ingredients

butylene glycol, camellia sinensis leaf extract, centella asiatica extract, chamomilla recutita (matricaria) flower extract, dimethyl sulfone, glycyrrhiza glabra (licorice) root extract, isopropyl myristate, polygonum cuspidatum root extract, rosmarinus officinalis (rosemary) leaf extract, scutellaria baicalensis root extract, SD alcohol, water

Questions Or Comments?

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