FDA.reportPublic FDA data

Arthritis Cream

Manufacturer
CVS
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:35

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate 10%

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: Arthritis Simple backache muscle strains sprains bruises

Warnings

WARNINGS SECTION

For external use only Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Directions And Dosage

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 not more than 4 times daily Children 12 years and younger : ask a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, cetyl alcohol, glycerin, mineral oil, phenoxyethanol, stearic acid, triethanolamine, water, xanthan gum

Label Images#

213140 Arthritis Cream 3 oz tube proof no dieline
213140 Arthritis Cream 3 oz tube proof no dieline
213140 Arthritis Cream 3 oz carton proof no dieline
213140 Arthritis Cream 3 oz carton proof no dieline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313518trolamine salicylate 10 % Topical CreamPSN5
313518trolamine salicylate 100 MG/ML Topical CreamSCD5
313518trolamine salicylate 10 % Topical CreamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-990-10Arthritis Cream85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-990ARTHRITIS CREAM (TROLAMINE SALICYLATE 10%) CREAM [CVS]5Current NDC, Legacy NDC, 1 package rows20241213_d1663f50-479b-4d55-e053-2995a90a223f.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-99051316-990-10

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TROLAMINE SALICYLATEH8O4040BHDACTIB
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate 10%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: Arthritis Simple backache muscle strains sprains bruises

WARNINGS SECTION

WARNINGS SECTION

For external use only Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

DOSAGE & ADMINISTRATION SECTION

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 not more than 4 times daily Children 12 years and younger : ask a doctor

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Store at 20° - 25°C (68° - 77°F)

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, cetyl alcohol, glycerin, mineral oil, phenoxyethanol, stearic acid, triethanolamine, water, xanthan gum

Source Document#

Source XML