FDA.reportPublic FDA data

Thermacare Ultra

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:48:36

Label at a glance#

ProductThermacare Ultra
Active ingredientCAMPHOR (SYNTHETIC), CAPSICUM OLEORESIN, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • sprains • strains • bruises

Dosage and administration

• use only as directed • when first opening the tube, remove the cap then peel away the foil seal. Close the cap then use the flip-top to dispense the product. • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily • children under 12 years of age: consult your doctor • wash hands after applying

Storage and handling

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Capsicum oleoresin (equivalent to 0.025% capsaicin)

Menthol 10%

Methyl salicylate 15%

Purposes

OTC - PURPOSE SECTION

Topical analgesic

Topical analgesic

Topical analgesic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • sprains
  • strains
  • bruises

Warnings

WARNINGS SECTION

For external use only

  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • redness over the affected area

When using this product

OTC - WHEN USING SECTION

  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or if symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash, itching or skin irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • when first opening the tube, remove the cap then peel away the foil seal. Close the cap then use the flip-top to dispense the product.
  • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult your doctor
  • wash hands after applying

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, cetyl alcohol, cetyl esters wax, emulsifying wax, oleth-3-phosphate, purified water, stearic acid, trolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-323-3383

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-3023-11

NEW

ThermaCare®

4 POWERFUL
PAIN FIGHTING
INGREDIENTS

ULTRA
PAIN
RELIEVING
CREAM

Arthritis & Joint Pain
Back & Body Aches
Sprains & Strains
Sore Muscles

Deep
Penetrating
Relief of
Tough Pain

NET WT 2.5 OZ (70.9 g)

PRINCIPAL DISPLAY PANEL - 70.9 g Tube Carton
PRINCIPAL DISPLAY PANEL - 70.9 g Tube Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-3023-11GM - Gram0573-30233a8a56d9-215b-48d3-bdcf-dc6fc93ed22112022-06-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-30230573-3023-11, 0573-3023-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CAPSICUM OLEORESINUW86K581WYACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL ESTERS WAXD072FFP9GUIACT
POLAWAX POLYSORBATEQ504PL8E0VIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
9695df96-6bc5-4c5a-a11e-e2cc2d7e9ec8844f8462-c8b7-4ace-b9b3-e7b05795054a2021-03-22WarningsExact identifier
spl id: 9695df96-6bc5-4c5a-a11e-e2cc2d7e9ec8
spl set id: 844f8462-c8b7-4ace-b9b3-e7b05795054a

Reported adverse events (FAERS/openFDA)#

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