FDA.reportPublic FDA data

teds topical pain cream

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 cream
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Use only as directed​ adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl 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: • simple back ache • arthritis • strains • bruises and • sprains

Warnings

WARNINGS SECTION

For external use only​

Allergy Alert

SPL UNCLASSIFIED SECTION

If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad

Ask a physician before use if

OTC - ASK DOCTOR SECTION

  • you have redness over the affected area

When using this product

OTC - WHEN USING SECTION

​ • use only as directed • avoid contact with eyes and muscous membranes • do not bandage tightly

Stop use and ask a physician if

OTC - STOP USE SECTION

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breast-feeding

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Use only as directed​

adults and children 2 years of age and older:

  • apply to affected area not more than 3 or 4 times daily

children under 2 years of age: consult a physician

Other Information

OTHER SAFETY INFORMATION

Store at 20ºC to 25ºC (68ºF - 77ºF)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (deionized water), Arnica Montana (arnica) Extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, PEG-100 stearate, phenoxyethanol, polysorbate 20, resveratrol, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TedspaincreamTedspaincream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311635methyl salicylate 10 % Topical CreamPSN2
311635methyl salicylate 100 MG/ML Topical CreamSCD2
311635methyl salicylate 10 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-210-032024-01-30C16284748780-11030e364-fc0a-111a-e063-dadaa90a10e2ted's Brain Science Products pain cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-210-03teds topical pain cream85 g in 1 TUBECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-210TEDS TOPICAL PAIN CREAM (METHYL SALICYLATE 10%) CREAM [COSMETIC SPECIALTY LABS, INC.]2Legacy NDC, 1 package rows20210112_849d6e28-a6c1-7f49-e053-2a91aa0a497d.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-21058133-210-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CETEARYL OLIVATE58B69Q84JOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
RESVERATROLQ369O8926LIACT
SODIUM LAURYL GLYCOL CARBOXYLATE8L0472VMYLIACT
SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMERK9R4VJQ1IBIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT

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
b8a17775-e842-12ce-e053-2a95a90a2887849d6e28-a6c1-7f49-e053-2a91aa0a497d2021-01-11WarningsExact identifier
spl id: b8a17775-e842-12ce-e053-2a95a90a2887
spl set id: 849d6e28-a6c1-7f49-e053-2a91aa0a497d

Reported adverse events (FAERS/openFDA)#

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