TRICALM  HYDROGEL- aluminum acetate gel 
Modular Thermal Technologies LLC Dba Life Wear Technologies

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®
Hydrogel

Drug Facts

Active ingredient

Aluminum acetate (0.2%)

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.

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, dehydroacetic acid, ethylhexylglycerin, glycine, hexylene glycol, malic acid, phenoxyethanol, purified water, strontium chloride hexahydrate, xanthan gum.

Questions?

Call 855-TRI-CALM

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

TRICALM®

Rapid Relief
From Itching,
Burning
& Stinging

SOOTHING
ITCH RELIEF
HYDROGEL

Steroid-Free
Aluminum Acetate Astringent

2 FL OZ (60mL)

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

Principal Display Panel Tube

TRICALM      Steroid-Free Hydrogel

For Itching Burning and Stinging 

                     2.0 FLOZ ( 60mL)

Principal Display Panel Tube

Principal Display Panel Tube

TRICALM   HYDROGEL
aluminum acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71207-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCINE (UNII: TE7660XO1C)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MALIC ACID (UNII: 817L1N4CKP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71207-100-101 in 1 CARTON11/02/2016
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:71207-100-201 in 1 CARTON11/02/2016
260 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2013
Labeler - Modular Thermal Technologies LLC Dba Life Wear Technologies (131710969)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(71207-100)

Revised: 3/2017
Document Id: b3e5758e-a314-43fc-aabf-d0c5b9b430be
Set id: 5cb42ffb-3655-4c38-bf84-1cf33c82df10
Version: 1
Effective Time: 20170323
 
Modular Thermal Technologies LLC Dba Life Wear Technologies