Healthwise Pain Relief Spray
FDA Label NDC 71101-067

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 Pain Relief (NDC 71101-067). 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

External Analgesic

Uses

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

Warnings

For external use only.

Flammable.Do not use while smoking or near heat or flame

When Using This Product

When using this product

keep out of eyes. In case of contact with 

eyes, flush thoroughly with water • avoid contact with broken skin 

• do not bandage tightly • do not use with heating pad • contents

under pressure. Do not puncture or incinerate. Do not store at

temperature above 120°F

Stop Use And Ask A Doctor If

  • condition worsens
  • rash or irritation develops and lasts for more than 7 days or clear up and occur again within 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:ask a doctor.

Other Information

Store out of direct sunlight, in a cool dry, well-ventilated area

Inactive Ingredients

butylene glycol, camellia sinensis leaf extract, centella asiatica extract, chamomilla recutita (matricaria) flower extract, denatonium benzoate, 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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