MARATHON PAIN RELIEF TOPICAL ANALGESIC- menthol 3.0% lotion

Marathon Pain Relief by

Drug Labeling and Warnings

Marathon Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

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

INGREDIENTS AND APPEARANCE

MARATHON PAIN RELIEF  TOPICAL ANALGESIC
menthol 3.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	menthol	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-001-13	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/15/2013

Labeler - Cosmetic Specialty labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty labs, Inc.		032973000	manufacture(58133-001)