MedPath

Arthritis Relief

Approved
Approval ID

a253730a-2187-07de-e053-2a95a90a9877

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 2, 2020

Manufacturers
FDA

Geiss, Destin & Dunn, Inc

DUNS: 076059836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trolamine Salicylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-207
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Trolamine Salicylate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 2, 2020
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
TROLAMINE SALICYLATEActive
Quantity: 10 g in 100 g
Code: H8O4040BHD
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/27/2019

![Carton](/dailymed/image.cfm?name=GoodSense+Arthritis+Cream_GDS- ASPR3_25_VIEW+copy.jpg&id=898577)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/1/2019

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/1/2019

Trolamine Salicylate 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/1/2019

Topical Analgesic

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/1/2019

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strain, sprains, bruises, cramps.

WARNINGS SECTION

LOINC: 34071-1Updated: 11/1/2019

For external use only.

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

When using this productuse 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 mucous membranes, do not apply to wounds or damaged skin.

Stop use and ask a doctorif condition worsens or symptoms persist for more than 7 days if symptoms clear up and occur again within a few days, or if redness or irritation develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/18/2025

Ask a health-care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/14/2019

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/27/2019

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.

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Arthritis Relief - FDA Drug Approval Details