THERACARE MUSCLE AND JOIN PAIN RELIEVING CREAM- menthol, methyl salicylate cream

TheraCare Muscle and Join Pain Relieving Cream by

Drug Labeling and Warnings

TheraCare Muscle and Join Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Menthol 10%

Methyl salicylate 15%

Active ingredients	Purpose
Menthol 10%	Topical analgesic
Methyl salicylate 15%	Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• excessive skin irritation occurs
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a physician.

Other information

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive ingredients

borax, butylated hydroxy1oluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water

TheraCare Muscle & Joint Pain Relief Cream

INGREDIENTS AND APPEARANCE

THERACARE MUSCLE AND JOIN PAIN RELIEVING CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROLAMINE (UNII: 9O3K93S3TK)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM BORATE (UNII: 91MBZ8H3QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-012-01	1 in 1 CARTON	05/01/2024
1		56.6 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 Drug	M017	05/01/2024

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(71101-012)