Label: THERMACARE ULTRA- camphor, capsicum oleresin, menthol, methyl salicylate cream
- NDC Code(s): 0573-3023-11, 0573-3023-14
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 22, 2021
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- Active Ingredients
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
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
- 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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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 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 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 01/31/2022 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 01/31/2022 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 01/31/2022 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)