Marathon Pain Relief Topical Analgesic: Package Insert and Label Information

MARATHON PAIN RELIEF TOPICAL ANALGESIC- menthol 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.

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.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
menthol (MENTHOL) menthol 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CHAMAEMELUM NOBILE FLOWER
ARNICA MONTANA FLOWER
FD&C BLUE NO. 1
BUTYLENE GLYCOL
CALENDULA OFFICINALIS FLOWER
CAPSICUM
CARBOMER 934
CENTAUREA CYANUS FLOWER
CETOSTEARYL ALCOHOL
CORIANDER OIL
EMU OIL
HAMAMELIS VIRGINIANA TOP
HYPERICUM PERFORATUM
CHAMOMILE
DIMETHYL SULFONE
WATER
SALIX ALBA BARK
ISOPROPYL ALCOHOL
SORBITOL
EDETATE SODIUM
TILIA X EUROPAEA FLOWER
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58133-001-13 113 g in 1 TUBE None
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 Operations
Cosmetic Specialty labs, Inc. 032973000 manufacture (58133-001)

Revised: 03/2013 Cosmetic Specialty labs, Inc.

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