KYMARO  ROLL ON RELIEF- 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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Kymaro®
Roll on Relief Cream

Active ingredients Purpose
Menthol 12% Topical Analgesic
Camphor 6% Topical Analgesic

Uses

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

Warnings

For external use only.

  • Flammable: Keep from heat and flame. Use only as directed.
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, wrap, hot water bottle or any heating element.

When using this product do not get into eyes

  • avoid contact with other mucous membranes
  • if eye contact occurs, flush immediately with water

Stop 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 care 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 Coploymer, Corn Starch Modified, Linum Usitatissmum (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 Octenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL - 85g Bottle Label

KYMARO®
HEALTH & BEAUTY / SPA ESSENTIALS

NEW!

Roll-On
RELIEF
Cream

No Mess
APPLICATOR

PENETRATING
PAIN RELIEF

EFFECTIVE STRENGTH

PAIN RELIEVING CREAM

NET WT 3 OZ (85g)

Principal Display Panel - 85g Bottle Label
KYMARO   ROLL ON RELIEF
menthol and camphor (synthetic) cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-541
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10.2 g  in 85 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.1 g  in 85 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
STARCH, CORN (UNII: O8232NY3SJ)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
METHYL LACTATE, L- (UNII: 0379G9C44S)  
LAURYL LAURATE (UNII: GPW77G0937)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-541-13 85 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 09/24/2012
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
Name Address ID/FEI Business Operations
Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-541)

Revised: 11/2013
Document Id: 8c224047-985e-4059-94b6-0cdfd0e4d137
Set id: 5cff1fd3-89cc-439a-b704-0fa8e4161478
Version: 1
Effective Time: 20131112
 
Concept Laboratories, Inc.