THERACARE MUSCLE AND JOIN PAIN RELIEF CREAM- menthol, methyl salicylate cream 
Veridian Healthcare

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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TheraCare Muscle & Join Pain Relief Cream

Drug Facts

Menthol 10%

Methyl salicylate 15%

Active ingredientsPurpose
Menthol 10%Topical analgesic
Methyl salicylate 15%Topical analgesic

Uses

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

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

Other information

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive ingredients

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water.

TheraCare Muscle & Joint Pain Relief Cream

labelPack

THERACARE MUSCLE AND JOIN PAIN RELIEF CREAM 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-212-011 in 1 CARTON09/01/2021
156.6 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 finalpart34809/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-212)

Revised: 8/2022
Document Id: e5f9109e-3c6c-2311-e053-2995a90af6b1
Set id: cb0612fc-2bc3-919c-e053-2995a90ac2a6
Version: 2
Effective Time: 20220811
 
Veridian Healthcare