FDA.reportPublic FDA data

Tru-micin

Manufacturer
Truceuticals, LLC
Effective date
2013-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:39

Label at a glance#

ProductTru-micin
Active ingredientTrolamine
Label structure10 sections

Indications and uses

Temporary relief of pain associated with: Joint and Muscle Inflammation Nerve damage Fitness and Sports Injuries

Dosage and administration

Adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed repeat if necessary, but not more than 4 times daily

Storage and handling

Store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Trolamine salicylate 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of pain associated with:

  • Joint and Muscle Inflammation
  • Nerve damage
  • Fitness and Sports Injuries

Warnings

WARNINGS SECTION

For external use only.

Allergy alert

SPL UNCLASSIFIED SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

use only as directed

  • do not bandage tightly or use with a heating pad
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 7 days or clear up and occur again within a few days

  • redness is present
  • irritation develops
  • condition worsens

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek immediate medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed
  • repeat if necessary, but not more than 4 times daily

Other Information

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha-lipoic acid, Caprylyl Glycol, Cetylalcohol, Coco Caprylate/Caprate, Curcuma longa, Dimethicone, DMDM Hydantoin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Ocimum sanc, Octyl Methoxycinnamate, Olibanum, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Rosmarinus, Salix Alba, Stearic Acid, Stearyl Stearate, Tocopheryl Acetate (Vitamin-E), Water, Zingiber

Questions?

OTC - QUESTIONS SECTION

Call 877-669-4227

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Odorless • Non-greasy
Fast-acting

Tru-micin®

Topical Analgesic

Temporary relief of pain
associated with
joint, muscle inflammation
and nerve damage

3.5 fl. oz (100 ml)

NDC 51230-418-01

Principal Display Panel - 100 mL Tube Label
Principal Display Panel - 100 mL Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313519trolamine salicylate 10 % Topical LotionPSN1
1433915Tru-micin 10 % Topical LotionPSN1
1433915trolamine salicylate 100 MG/ML Topical Lotion [Tru-micin]SBD1
313519trolamine salicylate 100 MG/ML Topical LotionSCD1
313519trolamine salicylate 10 % Topical LotionSY1
1433915Tru-micin 10 % Topical LotionSY1
1433915Tru-micin 100 MG/ML Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51230-418-012019-11-27C16284748780-19855d018-d5b9-cd31-e053-dbdaa90ab51aTru-micin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51230-418-01Tru-micin100 mL in 1 TUBELOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51230-418TRU-MICIN (TROLAMINE) LOTION [TRUCEUTICALS, LLC]1Legacy NDC, 1 package rows20130608_49c41d92-9c48-4245-b251-13226fb11c94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51230-418-01ML - Milliliter51230-418e5e5c938-46a9-468e-aa5d-9cfb6e9bf04d12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TrolamineACTIVE INGREDIENT9O3K93S3TK1
TrolamineACTIVE MOIETY9O3K93S3TK1
.Alpha.-Lipoic AcidINACTIVE INGREDIENT73Y7P0K73Y1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
Coco-CaprylateINACTIVE INGREDIENT4828G836N61
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
DMDM HydantoinINACTIVE INGREDIENTBYR0546TOW1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GingerINACTIVE INGREDIENTC5529G5JPQ1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75J1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2M1
Ocimum Tenuiflorum TopINACTIVE INGREDIENT34T63W8ULS1
OctinoxateINACTIVE INGREDIENT4Y5P7MUD511
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
RosemaryINACTIVE INGREDIENTIJ67X351P91
Salix Alba BarkINACTIVE INGREDIENT205MXS71H71
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
Stearyl StearateINACTIVE INGREDIENT5WX2EGD0DK1
TurmericINACTIVE INGREDIENT856YO1Z64F1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51230-41851230-418-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Trolamine9O3K93S3TKACTIB
GlycerinPDC6A3C0OXIACT
Coco-Caprylate4828G836N6IACT
Glyceryl Monostearate230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
Octinoxate4Y5P7MUD51IACT
Stearic Acid4ELV7Z65APIACT
Cetyl Alcohol936JST6JCNIACT
Stearyl Stearate5WX2EGD0DKIACT
Dimethicone92RU3N3Y1OIACT
Petrolatum4T6H12BN9UIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
PhenoxyethanolHIE492ZZ3TIACT
Caprylyl Glycol00YIU5438UIACT
Ethylhexylglycerin147D247K3PIACT
Hexylene GlycolKEH0A3F75JIACT
DMDM HydantoinBYR0546TOWIACT
Water059QF0KO0RIACT
Turmeric856YO1Z64FIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
.Alpha.-Lipoic Acid73Y7P0K73YIACT
Salix Alba Bark205MXS71H7IACT
Ocimum Tenuiflorum Top34T63W8ULSIACT
GingerC5529G5JPQIACT
RosemaryIJ67X351P9IACT

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 3 · 179 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEG-100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
DMDM HydantoinDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii candidate
Hexylene GlycolHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 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
65a2b1c2-7a19-4df2-8695-5b5c54983d6549c41d92-9c48-4245-b251-13226fb11c942013-06-05WarningsExact identifier
spl id: 65a2b1c2-7a19-4df2-8695-5b5c54983d65
spl set id: 49c41d92-9c48-4245-b251-13226fb11c94

Reported adverse events (FAERS/openFDA)#

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