teds topical pain gel roll on

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:45

Label at a glance#

Productteds topical pain gel roll on
Active ingredientTROLAMINE SALICYLATE
Label structure12 sections

Indications and uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • arthritis • simple back ache • muscle strains • sprains • bruises • cramps

Dosage and administration

Use only as directed​ 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 3 to 4 times daily children under 2 years of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate - 10%

Purpose

OTC - PURPOSE SECTION

Topical Pain Relief

Uses

INDICATIONS & USAGE SECTION

For the temporarily relief of minor aches and pains of muscles and joints associated with: • arthritis • simple back ache • muscle strains • sprains • bruises • cramps

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 • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Use only as directed​

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 3 to 4 times daily

children under 2 years of age: Ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Caprylyl Glycol, Carbomer, Cyclomethicone, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water, Resveratrol, Salix Alba (Willow) Bark Extract, Triethanolamine.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TedsRonOnTedsRonOnrollonboxrollonbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198881trolamine salicylate 10 % Topical GelPSN2
198881trolamine salicylate 0.1 MG/MG Topical GelSCD2
198881triethanolamine salicylate 10 % Topical GelSY2
198881trolamine salicylate 10 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-211-032024-01-30C16284748780-11030e365-3f3d-111a-e063-dadaa90a10e2ted's Brain Science Products pain gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-211-03teds topical pain gel roll on85 g in 1 TUBE, WITH APPLICATORGEL852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-211TEDS TOPICAL PAIN GEL ROLL ON (TROLAMINE SALICYLATE 10%) GEL [COSMETIC SPECIALTY LABS, INC.]2Legacy NDC, 1 package rows20210112_84af0590-db35-2b23-e053-2a91aa0a89c0.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-21158133-211-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
b8a17ba9-85cb-ad56-e053-2995a90a14d984af0590-db35-2b23-e053-2a91aa0a89c02021-01-11WarningsExact identifier
spl id: b8a17ba9-85cb-ad56-e053-2995a90a14d9
spl set id: 84af0590-db35-2b23-e053-2a91aa0a89c0

Reported adverse events (FAERS/openFDA)#

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