FDA.reportPublic FDA data

Real Time Pain Relief Therapeutic Hand Cream

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:03

Label at a glance#

ProductReal Time Pain Relief Therapeutic Hand Cream
Active ingredientTROLAMINE SALICYLATE
Label structure7 sections

Indications and uses

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

Dosage and administration

adults and children over 2 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 2 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredient                               Purpose

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate - 10%                Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings For 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 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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 2 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 2 years or younger: ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Emu Oil, Fragrance, Laureth-7, Methylsulfonylmethane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Purified Water, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Triethanolamine.

Package Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313519trolamine salicylate 10 % Topical LotionPSN1
313519trolamine salicylate 100 MG/ML Topical LotionSCD1
313519trolamine salicylate 10 % Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-400-042024-01-30C16284748780-11030e365-306d-111a-e063-dadaa90a10e2Real Time Pain Relief Therapeutic Hand Cream
58133-400-122024-01-30C16284748780-11030e365-306d-111a-e063-dadaa90a10e2Real Time Pain Relief Therapeutic Hand Cream
58133-400-152024-01-30C16284748780-11030e365-306d-111a-e063-dadaa90a10e2Real Time Pain Relief Therapeutic Hand Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-400-04Real Time Pain Relief Therapeutic Hand Cream120 mL in 1 TUBELOTION1201
58133-400-12Real Time Pain Relief Therapeutic Hand Cream345 mL in 1 BOTTLE, PUMPLOTION3451
58133-400-15Real Time Pain Relief Therapeutic Hand Cream45 mL in 1 TUBELOTION451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-400REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM (TROLAMINE SALICYLATE 10%) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 3 package rows20180110_61e1af5e-d782-a3b6-e053-2a91aa0ad098.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-40058133-400-15, 58133-400-04, 58133-400-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFONE9H4PO4Z4FTIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EMU OIL344821WD61IACT
LAURETH-7Z95S6G8201IACT
BUTYROSPERMOL6SF0L0FL42IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
TROLAMINE SALICYLATEH8O4040BHDACTIB
OLEA EUROPAEA FRUIT VOLATILE OIL8E7358CX1JIACT
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOLY050HYR4XAIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
SALIX ALBA BARK205MXS71H7IACT

Source Document#

Source XML · Source PDF

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
61e1af5e-d783-a3b6-e053-2a91aa0ad09861e1af5e-d782-a3b6-e053-2a91aa0ad0982018-01-03WarningsExact identifier
spl id: 61e1af5e-d783-a3b6-e053-2a91aa0ad098
spl set id: 61e1af5e-d782-a3b6-e053-2a91aa0ad098

Reported adverse events (FAERS/openFDA)#

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