FDA.reportPublic FDA data

TriCalm

Manufacturer
Modular Thermal Technologies LLC Dba Life Wear Technologies | Sheffield Pharmaceuticals LLC
Effective date
2017-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:16

Label at a glance#

ProductTriCalm Hydrogel
Active ingredientALUMINUM ACETATE
Label structure10 sections

Indications and uses

For temporary relief of minor skin irritations due to: poison ivy poison oak poison sumac insect bites athlete's foot  rashes caused by soaps, detergents, cosmetics or jewelry

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum acetate (0.2%)

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor skin irritations due to:

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not apply to open wounds.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 855-TRI-CALM

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonPRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton
PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

Principal Display Panel Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRICALM      Steroid-Free Hydrogel

For Itching Burning and Stinging 

                     2.0 FLOZ ( 60mL)

Principal Display Panel TubePrincipal Display Panel Tube

Principal Display Panel TubePrincipal Display Panel Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1594642aluminum acetate 0.2 % Topical GelPSN1
1594647TriCalm 2 % Topical GelPSN1
1594647aluminum acetate 0.002 MG/MG Topical Gel [Tricalm]SBD1
1594642aluminum acetate 0.002 MG/MG Topical GelSCD1
1594642aluminum acetate 0.2 % Topical GelSY1
1594647Tricalm 0.002 MG/MG Topical GelSY1
1594647Tricalm 2 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71207-100TRICALM HYDROGEL (ALUMINUM ACETATE) GEL [MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES ]1Current NDC, Legacy NDC20181115_5cb42ffb-3655-4c38-bf84-1cf33c82df10.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71207-10071207-100-10, 71207-100-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM ACETATE80EHD8I43DACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DEHYDROACETIC ACID2KAG279R6RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCINETE7660XO1CIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MALIC ACID817L1N4CKPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
STRONTIUM CHLORIDE HEXAHYDRATEO09USB7Z44IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
ndc (package): 71207-100-20
ndc (package): 71207-100-10
ndc (product): 71207-100
ndc11 (package): 71207010010
ndc11 (package): 71207010020
spl id: b3e5758e-a314-43fc-aabf-d0c5b9b430be
spl set id: 5cb42ffb-3655-4c38-bf84-1cf33c82df10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.