VANISHING SCENT MUSCLE RUB GEL- menthol gel 
McCure Health Solutions Inc.

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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Vanishing Scent Muscle Rub Gel

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 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

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

Other information

• Store between 20 C and 25 C (68 F and 77 F) • Lot No. & Exp. Date. see box or crimp of tube

Inactive ingredients

CARBOMER 940, DL-CAMPHOR, ISOPROPANOL, METHYLPARABEN, POLYSORBATE 60, POTASSIUM SORBATE, PURIFIED WATER, STEARYL ALCOHOL, TROLAMINE

Product Label

MUSCLE RUB

VANISHING SCENT MUSCLE RUB GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52486-012-571 in 1 CARTON03/27/2015
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 finalpart34803/27/2015
Labeler - McCure Health Solutions Inc. (053034873)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Dedi Medical Device Co., Ltd.544458936manufacture(52486-012)

Revised: 12/2016
Document Id: 44bd9411-0c55-1729-e054-00144ff88e88
Set id: 631d8f32-521a-4264-902f-625ffd25ae7a
Version: 2
Effective Time: 20161228
 
McCure Health Solutions Inc.