RETADOLOR  PENETRATING COOL THERAPY- menthol and camphor (synthetic) cream 
Concept Laboratories, 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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RETADOLOR
The Anti-Pain
PENETRATING COOL THERAPY CREAM

Active ingredientPurpose
Menthol 12%Pain Relieving
Camphor 6%Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable: Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

  • if pregnant or nursing, seek the advice of a health professional before using

Directions

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octrenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate

Exclusively manufactured for
LaCar Sales & Marketing Inc.
by Concept Laboratories, Inc.
Chicago, IL 60642
www.retadolor.com
#CL9957

PRINCIPAL DISPLAY PANEL - 85g Bottle Label

RETADOLOR
NDC 64058-241-13
The Anti-Pain

PENETRATING COOL THERAPY CREAM

Topical Analgesic for the Relief of
TENSION, STRAINS, SPRAINS
& MUSCLE PAIN

Contains Powerful
Menthol & Camphor
with Vanishing
Scent

ANTI-INFLAMMATORY
OMEGA
3, 6 & 9
with
IcePearls

NET WT. 3 OZ (85g)

Principal Display Panel - 85g Bottle Label
RETADOLOR   PENETRATING COOL THERAPY
menthol and camphor (synthetic) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10.2 g  in 85 g
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)5.1 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
LAURYL LAURATE (UNII: GPW77G0937)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-241-1385 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34807/27/2009
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE

Revised: 9/2011
Document Id: d345f290-cb01-4606-a576-173e125f349c
Set id: 13bca1a2-56a4-4237-ae6d-541f67213a80
Version: 1
Effective Time: 20110909
 
Concept Laboratories, Inc.