RED LION RELIEF- menthol cream 
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

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 the eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

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

If pregnant or breast-feeding

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Adults and children over 12 years

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

Children 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Cymbopogon Martinii (Palmarosa) Oil, Eucalyptus Globulus Leaf Oil, Hamamelis Virginiana (Witch Hazel) Bark / Leaf / Twig Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, Sorbitol, Tocopheryl Acetate, Triethanolamine.

PRINCIPAL DISPLAY PANEL

Display Panel
RED LION RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-075
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)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ORANGE OIL (UNII: AKN3KSD11B)  
PALMAROSA OIL (UNII: 0J3G3O53ST)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
SORBITOL (UNII: 506T60A25R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-075-04115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2012
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-075)

Revised: 1/2014
Document Id: 5ef26b5b-5f72-4f45-8d89-8d40b704a38a
Set id: 5523c67d-6fb5-4cbc-8828-db146cbf6b92
Version: 1
Effective Time: 20140127
 
Cosmetic Specialty labs, Inc.