KALAYA PAIN RELIEF 6X WITH ARNICA- pain relief cream cream 
Avaria Health & Beauty Corp

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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Avaria







Kalaya- 3 package put ups. Two tubes and one roller applicator.

active ingredients

keep out of reach

purpose

inactives

warnings

usage

dosage

pdp

Roller Ball PDP

Roller

KALAYA PAIN RELIEF 6X WITH ARNICA 
pain relief cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE11 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
RICE BRAN OIL (UNII: LZO6K1506A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
DIETHYLENE GLYCOL MONOPHENYL ETHER (UNII: LZU6ET206Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0003-1120 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
2NDC:43493-0003-250 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
3NDC:43493-0003-3120 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2018
Labeler - Avaria Health & Beauty Corp (251366043)

Revised: 12/2022
Document Id: f05746fd-7f52-77ac-e053-2a95a90aece8
Set id: 60198d2e-4de3-3fa0-e053-2a91aa0afaf7
Version: 17
Effective Time: 20221221
 
Avaria Health & Beauty Corp