TriCalm ® Extra Strength Spray

Manufacturer: Cosmederm Bioscience
Effective date: 2015-07-01
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:43:02

Label at a glance#

ProductTriCalm Extra Strength

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 (0.3%)

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.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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, edetate disodium, glycerin, lactic acid, phenoxyethanol, polysorbate 80, purified water, strontium nitrate.

Questions?

OTC - QUESTIONS SECTION

Call 855-TRI-CALM

PRINCIPAL DISPLAY PANEL - 55 mL Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH SPRAY

TRICALM^®

FOR ITCHING, BURNING AND STINGING

1.86 FL OZ (55mL)

Principal Display Panel - 55 mL Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1657022	aluminum acetate 0.3 % Topical Spray	PSN	2
1657025	TRICALM 0.3 % Topical Spray	PSN	2
1657025	aluminum acetate 3 MG/ML Topical Spray [Tricalm]	SBD	2
1657022	aluminum acetate 3 MG/ML Topical Spray	SCD	2
1657022	aluminum acetate 0.3 % Topical Spray	SY	2
1657025	TriCalm 0.3 % Topical Spray	SY	2
1657025	Tricalm 3 MG/ML Topical Spray	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76312-002-01	2020-01-31	C162847	48780-1	9d75b9d0-c9b5-f424-e053-dadaa90a57ce	TriCalm ® Extra Strength Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76312-002-01	TriCalm Extra Strength	1 in 1 BOX	SOLUTION	1		2
76312-002-01	TriCalm Extra Strength	55 mL in 1 TUBE	SOLUTION	55		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76312-002	TRICALM EXTRA STRENGTH (ALUMINUM ACETATE) SOLUTION [COSMEDERM BIOSCIENCE]	2	Legacy NDC, 2 package rows	20150714_1d14fbd9-7bf4-4e43-b061-96d3d3036325.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Aluminum Acetate	ACTIVE INGREDIENT	80EHD8I43D	2
ALUMINUM CATION	ACTIVE MOIETY	3XHB1D032B	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
STRONTIUM NITRATE	INACTIVE INGREDIENT	BDG873AQZL	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

TriCalm Extra Strength
Aluminum Acetate
ALUMINUM CATION
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
EDETATE DISODIUM
GLYCERIN
LACTIC ACID
PHENOXYETHANOL
POLYSORBATE 80
WATER
STRONTIUM NITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76312-002	76312-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Aluminum Acetate	80EHD8I43D	ACTIB
BUTYLENE GLYCOL	3XUS85K0RA	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
LACTIC ACID	33X04XA5AT	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
STRONTIUM NITRATE	BDG873AQZL	IACT

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 5 · 256 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	53 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CREAM / VAGINAL	0.81 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAVENOUS		2232 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	AEROSOL, FOAM / TOPICAL		11 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SUSPENSION / TOPICAL	0.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAMUSCULAR	1.16 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION, SOLUTION / INTRAVENOUS		87 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
af5bb865-96b4-4654-acd9-a2de73895476			1d14fbd9-7bf4-4e43-b061-96d3d3036325	2015-07-01	Warnings	Exact identifier spl id: af5bb865-96b4-4654-acd9-a2de73895476 spl set id: 1d14fbd9-7bf4-4e43-b061-96d3d3036325

Reported adverse events (FAERS/openFDA)#

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