FDA.reportPublic FDA data

Pain Relieving Topical Analgesic

Manufacturer
Top Care | Product Quest Mfg
Effective date
2018-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:05

Label at a glance#

ProductPain Relieving Topical Analgesic
Active ingredientTROLAMINE SALICYLATE
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredient                               Purpose

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate - 10%                Topical Analgesic

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children over 12 years: • Apply generously to affected area • massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 4 times daily Children 12 years or younger: ask a doctor.

INDICATIONS & USAGE SECTION

​Uses ​temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps

WarningsFor external use only

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

OTC - WHEN USING SECTION

​When using this product • use only as directed • avoid taking a bath or shower within 1 hour before or after applying • do not bandage tightly or use with a heating pad • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313518trolamine salicylate 10 % Topical CreamPSN1
313518trolamine salicylate 100 MG/ML Topical CreamSCD1
313518trolamine salicylate 10 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-884-032020-01-31C16284748780-19d75b9d0-51a3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-884-03Pain Relieving Topical Analgesic89 g in 1 TUBECREAM891
36800-884-03Pain Relieving Topical Analgesic1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-884PAIN RELIEVING TOPICAL ANALGESIC (TROLAMINE SALICYLATE 10%) CREAM [TOP CARE]1Legacy NDC, 2 package rows20180627_dd95db29-0be7-4b46-8631-62b58bd267c2.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
36800-88436800-884-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE SALICYLATEH8O4040BHDACTIB
ALOE VERA LEAFZY81Z83H0XIACT
Cetyl Alcohol936JST6JCNIACT
GlycerinPDC6A3C0OXIACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMB7862WZ632IACT
PropylparabenZ8IX2SC1OHIACT
Stearic Acid4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
Water059QF0KO0RIACT

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
32912d46-af6d-4597-8713-48f3cd066a07dd95db29-0be7-4b46-8631-62b58bd267c22018-06-26WarningsExact identifier
spl id: 32912d46-af6d-4597-8713-48f3cd066a07
spl set id: dd95db29-0be7-4b46-8631-62b58bd267c2

Reported adverse events (FAERS/openFDA)#

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