Painzaway Balm
FDA Label NDC 10578-040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Painzaway Balm (NDC 10578-040). 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, do not, stop using and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Camphor 4.0%

Purpose

external analgesic ointment

Uses:

Temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises or simple backache.

Warnings

For external use only.

Avoid contact with the eyes.

When using this product, do not:

heat

microwave

use near open flames

add to hot water or any container where heating water.

May cause splattering and result in burns.

Do Not

use on wounds or damaged skin

bandage tightly

Stop Using And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult physician.

Other Information

Any Questions? 1-800-644-8327

website: www.botanicchoice.com

Use only if seal is unbroken.

Inactive Ingredients

White petrolatum, cassia oil, clove oil, siberian fir needle oil, cajeput oil, peppermint oil, natural beeswax.

* Please review the disclaimer below.