MAKESENSE EXTRA STRENGTH MUSCLE RUB- menthol gel 
Cherry Hill Sales Co

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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Drug Facts

Active Ingredients

Menthol 2.5%

Purpose

Topical Analgesic

Uses

■ temporarily relieves the minor arthritis pains of muscles and joints associated with ■ simple backache ■ bruises ■arthritis ■strains ■sprains

Warnings

For external use only. Flammable: Keep away from fire or flame

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

■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear-up and occur again within a few days, ■excessive skin irritation occurs ■ you have redness over the affected area

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ adults and children12 years of age and older: apply to affected area not more than 3-4 times 

■ children under 12 years of age: ask a doctor

Other information

■ store at room temperature 20 to 25C (68 to 77F)

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

Package Label

image description

MAKESENSE  EXTRA STRENGTH MUSCLE RUB
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
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:69020-200-1542.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2014
Labeler - Cherry Hill Sales Co (145959768)
Establishment
NameAddressID/FEIBusiness Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(69020-200)

Revised: 6/2014
Document Id: 35287aa1-48f4-48fd-9ec2-39971c02c56f
Set id: 1fecf16e-f676-4fbb-b2d5-79a0b0b5a526
Version: 1
Effective Time: 20140613
 
Cherry Hill Sales Co