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Kalaya Pain Relief 6X with Arnica

Dosage form: cream
Ingredients: METHYL SALICYLATE 11g in 100g, MENTHOL 4g in 100g, CAMPHOR (NATURAL) 4g in 100g, EUCALYPTUS OIL 0.5g in 100g
Labeler: Avaria Health & Beauty Corp
NDC Code: 43493-0003

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.

KALAYA PAIN RELIEF 6X WITH ARNICA 
pain relief cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE11 g  in 100 g
MENTHOL (MENTHOL) MENTHOL4 g  in 100 g
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)4 g  in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
RICE BRAN OIL 
CETYL ALCOHOL 
ISOPROPYL PALMITATE 
SODIUM HYDROXIDE 
GLYCERIN 
ARNICA MONTANA 
CARBOMER COPOLYMER TYPE A 
CETETH-10 PHOSPHATE 
DIHEXADECYL PHOSPHATE 
DIMETHYL SULFONE 
DIETHYLENE GLYCOL MONOPHENYL ETHER 
Packaging
#Item CodePackage Description
1NDC:43493-0003-1120 g in 1 TUBE
2NDC:43493-0003-250 g in 1 TUBE
3NDC:43493-0003-3120 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2018
Labeler - Avaria Health & Beauty Corp (248926979)

Document Id: 6f1fd35a-31c7-ed28-e053-2991aa0a61c0
Set id: 60198d2e-4de3-3fa0-e053-2a91aa0afaf7
Version: 2
Effective Time: 20180620
 
Avaria Health & Beauty Corp

Medically reviewed on Jun 20, 2018

Further information

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