THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT- menthol, unspecified form gel 
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.

----------

TheraCare Pain Relieving Muscle Vanishing Scent Rub

Drug Facts

Active ingredient

Menthol 2.5%

Purpose

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

  • use only as directed
  • 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)

Inactive ingredients

benzyl alcohol, butylated hydroxtoluene, camphor, carbomer, DMDM hydantoin, edetate disodium, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

call 866-326-1313 (toll-free)

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

label

THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ISOCETETH-20 (UNII: O020065R7Z)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-218-011 in 1 CARTON11/01/2021
157 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 finalpart34811/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-218)

Revised: 2/2022
Document Id: d8c32445-eda1-4181-e053-2a95a90a7a5a
Set id: d166aa21-479b-6265-e053-2995a90aca53
Version: 2
Effective Time: 20220224
 
Veridian Healthcare