MARATHON PAIN RELIEF TOPICAL ANALGESIC- menthol 3.0% lotion 
Cosmetic Specialty labs, 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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ACTIVE INGREDIENT

Menthol 3.0%

PURPOSE

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

USES

Temporarily relieves minor pain associated with

WARNINGS

for external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin

Stop using and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation deveops

If pregnant or breast-feeding

ask a health professional before use

DIRECTIONS

adults and children over 12 years

  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Anthemis Nobilis Extract, Arnica Montana Flower Extract, Blue 1, Butylene Glycol, Calendula Officinalis Extract, Capsicum rutescens Fruit, Carbomer, Centaurea Cyanus Extract, Cetearyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum Perforatum Extract, Matricaria Chamomilla Extract, Methylsulfonylmethane, Purified Water, Salix Alba (Willow) Baril Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia Sylvestris Extract, Triethanolamine.

PRINCIPAL DISPLAY PANEL

Display Panel
MARATHON PAIN RELIEF  TOPICAL ANALGESIC
menthol 3.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) menthol3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CAPSICUM (UNII: 00UK7646FG)  
CARBOMER 934 (UNII: Z135WT9208)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CORIANDER OIL (UNII: 7626GC95E5)  
EMU OIL (UNII: 344821WD61)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
WATER (UNII: 059QF0KO0R)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SORBITOL (UNII: 506T60A25R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-001-13113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2013
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-001)

Revised: 3/2013
Document Id: 2f35d74d-d185-43b3-841e-6eaeef127ff9
Set id: c10d8212-857e-49a0-98b6-df46ca879138
Version: 1
Effective Time: 20130327
 
Cosmetic Specialty labs, Inc.