TRICALM  EXTRA STRENGTH - aluminum acetate solution 
Cosmederm Bioscience

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TriCalm®
Extra Strength Spray

Drug Facts

Active ingredient

Aluminum acetate (0.3%)

Purpose

Astringent

Uses

For temporary relief of minor skin irritations due to:

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

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
TRICALM   EXTRA STRENGTH
aluminum acetate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76312-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Acetate (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) Aluminum Acetate3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76312-002-011 in 1 BOX
155 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34703/01/2015
Labeler - Cosmederm Bioscience (054730518)

Revised: 7/2015
Document Id: af5bb865-96b4-4654-acd9-a2de73895476
Set id: 1d14fbd9-7bf4-4e43-b061-96d3d3036325
Version: 2
Effective Time: 20150701
 
Cosmederm Bioscience