TriCalm

Manufacturer
Cosmederm Bioscience
Effective date
2015-06-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:42:52

Label at a glance#

ProductTriCalm Hydrogel
Active ingredientALUMINUM ACETATE
Label structure9 sections

Indications and 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

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 n
  • 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 Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5X MORE
EFFECTIVE THAN
HYDROCORTISONE 1%*

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 Tube Carton
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1594642aluminum acetate 0.2 % Topical GelPSN4
1594647TriCalm 2 % Topical GelPSN4
1594647aluminum acetate 0.002 MG/MG Topical Gel [Tricalm]SBD4
1594642aluminum acetate 0.002 MG/MG Topical GelSCD4
1594642aluminum acetate 0.2 % Topical GelSY4
1594647Tricalm 0.002 MG/MG Topical GelSY4
1594647Tricalm 2 % Topical GelSY4

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76312-001-012020-01-31C16284748780-19d75b9d0-4696-f424-e053-dadaa90a57ceTriCalm ® Hydrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76312-001-01TriCalm Hydrogel60 mL in 1 TUBEGEL604
76312-001-01TriCalm Hydrogel1 in 1 BOXGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76312-001TRICALM HYDROGEL (ALUMINUM ACETATE) GEL [COSMEDERM BIOSCIENCE]4Legacy NDC, 2 package rows20150629_cd13ed7d-1e4a-4e7d-bd13-1f28e143a36c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM ACETATEACTIVE INGREDIENT80EHD8I43D4
ALUMINUM CATIONACTIVE MOIETY3XHB1D032B4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U4
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
GLYCINEINACTIVE INGREDIENTTE7660XO1C4
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J4
MALIC ACIDINACTIVE INGREDIENT817L1N4CKP4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
STRONTIUM CHLORIDE HEXAHYDRATEINACTIVE INGREDIENTO09USB7Z444
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

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
76312-00176312-001-01

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 68 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPSUSPENSION / ORAL180 mgExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAMUSCULAR68 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CSOLUTION / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPSOLUTION / ORAL16760 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPPOWDER, FOR SOLUTION / ORAL1230 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
20 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPTABLET / ORAL20 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET / ORAL163.31 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3.76 mgExact identifier — unii candidate
20 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RSHAMPOO / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CCAPSULE, DELAYED RELEASE / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RLOTION / TOPICAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPPOWDER, FOR SUSPENSION / ORAL1392 mgExact identifier — unii candidate
5 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates

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
ac9efe9d-e07c-41ad-9139-471cc18154e0cd13ed7d-1e4a-4e7d-bd13-1f28e143a36c2015-06-26WarningsExact identifier
spl id: ac9efe9d-e07c-41ad-9139-471cc18154e0
spl set id: cd13ed7d-1e4a-4e7d-bd13-1f28e143a36c

Reported adverse events (FAERS/openFDA)#

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