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

TheraCare Pain Relieving Muscle Vanishing Scent by

Drug Labeling and Warnings

TheraCare Pain Relieving Muscle Vanishing Scent by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 2.5%

Purpose

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

• 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

• 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 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

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

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-218
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	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-218-01	1 in 1 CARTON	11/01/2021
1		57 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	11/01/2021

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-218)