THERMACARE ULTRA- camphor, capsicum oleresin, menthol, methyl salicylate cream 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Camphor 3.1%

Capsicum oleoresin (equivalent to 0.025% capsaicin)

Menthol 10%

Methyl salicylate 15%

Purposes

Topical analgesic

Topical analgesic

Topical analgesic

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

Distributed by: Pfizer, Madison, NJ 07940 USA

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
THERMACARE ULTRA 
camphor, capsicum oleresin, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-3023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)31 mg  in 1 g
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.25 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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
ColorWHITE ((off white)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-3023-111 in 1 CARTON07/02/201801/31/2022
170.9 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0573-3023-141 in 1 CARTON07/02/201801/31/2022
2113.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/02/201801/31/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2021
Document Id: 9695df96-6bc5-4c5a-a11e-e2cc2d7e9ec8
Set id: 844f8462-c8b7-4ace-b9b3-e7b05795054a
Version: 3
Effective Time: 20210322
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC