Tricalm
FDA Label NDC 76312-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmederm Bioscience for the product Tricalm (NDC 76312-002). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

Other

Drug Facts

Active Ingredient

Aluminum acetate (0.3%)

Purpose

Astringent

Uses

For temporary relief of minor skin irritations due to:

  • poison ivy
  • poison oak
  • poison sumac
  • insect bites
  • athlete's foot n
  • rashes caused by soaps, detergents, cosmetics or jewelry

Warnings

For external use only.

Otc - When Using

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not apply to open wounds.
  • Temporary stinging may occur when applied to extremely dry, open or abraded skin.

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or symptoms last for more than 7 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children two years of age and older, apply to affected area as needed or as directed by a physician. Consult a physician for children under the age of two.

Inactive Ingredients

Butylene glycol, caprylyl glycol, edetate disodium, glycerin, lactic acid, phenoxyethanol, polysorbate 80, purified water, strontium nitrate.

Questions?

Call 855-TRI-CALM

Principal Display Panel - 55 Ml Tube Box

EXTRA STRENGTH SPRAY

TRICALM®

FOR ITCHING, BURNING AND STINGING

1.86 FL OZ (55mL)

Principal Display Panel (55 mL Tube Box)

Principal Display Panel (55 mL Tube Box)

* Please review the disclaimer below.