THERMACARE ULTRA- camphor, capsicum oleresin, menthol, methyl salicylate cream

Thermacare Ultra by

Drug Labeling and Warnings

Thermacare Ultra by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Camphor 3.1%	Topical analgesic
Capsicum oleoresin (equivalent to 0.025% capsaicin)	Topical analgesic
Menthol 10%	Topical analgesic
Methyl salicylate 15%	Topical analgesic

Uses

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

• arthritis
• simple backache
• sprains
• strains
• bruises

Warnings

For external use only

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

Do not use

• 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

• redness over the affected area

When using this product

• do not bandage tightly

Stop use and ask a doctor if

• 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

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

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

Directions

• 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

• store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions or comments?

Call toll-free 1-800-323-3383

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 70.9 g Tube Label

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

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)

INGREDIENTS AND APPEARANCE

THERMACARE ULTRA 
camphor, capsicum oleresin, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-3023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	31 mg  in 1 g
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSAICIN	0.25 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL ESTERS WAX (UNII: D072FFP9GU)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE ((off white))	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-3023-11	1 in 1 CARTON	07/02/2018
1		70.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0573-3023-14	1 in 1 CARTON	07/02/2018
2		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/02/2018

Labeler - Wyeth Consumer Healthcare LLC (828831730)