MUSCLE AND JOINT - menthol gel 
NeoPharm Co., Ltd.

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 ingredient

Menthol 2.5%

Uses

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

For external use only

Do not use

  • on wound s 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

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Package label

Muscle and joint pain relief rubimage of carton label

Purpose

Topical analgesic

MUSCLE AND JOINT 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0005
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)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
glycerin (UNII: PDC6A3C0OX)  
isopropyl alcohol (UNII: ND2M416302)  
methylparaben (UNII: A2I8C7HI9T)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0005-41 in 1 BOX
1113 g in 1 TUBE
2NDC:51141-0005-21 in 1 BOX
257 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/27/2010
Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 8/2010
Document Id: 3b72153a-2bc7-4878-baf4-af9193e68b13
Set id: 4a714458-6ee7-4a97-8b2b-8b473cae92d7
Version: 1
Effective Time: 20100818
 
NeoPharm Co., Ltd.