TRICALM EXTRA STRENGTH- aluminum acetate solution

TriCalm by

Drug Labeling and Warnings

TriCalm by is a Otc medication manufactured, distributed, or labeled by Cosmederm Bioscience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.

Stop use and ask a doctor if

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

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)

INGREDIENTS AND APPEARANCE

TRICALM   EXTRA STRENGTH
aluminum acetate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76312-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Acetate (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	Aluminum Acetate	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
STRONTIUM NITRATE (UNII: BDG873AQZL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76312-002-01	1 in 1 BOX
1		55 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	03/01/2015

Labeler - Cosmederm Bioscience (054730518)