KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF- methyl salicylate, menthol, camphor 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.

----------

Drug Facts

Active ingredients

Camphor 4%, 

Menthol 4%, 

Methyl salicylate 11%

Purpose

Topical Analgesic

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Warnings

For external use only

 Do not use

  When using this product

Stop use and ask a doctor


KEEP OUT OF REACH OF CHILDREN

if swallowed get medical help or contact a Poison Control Center right away. 

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Other information

• Store at 59°F - 77°F

Inactive ingredients

water, rice bran oil, cetyl alcohol, isopropyl palmitate, sodium hydroxide, glycerin, eucalyptus oil, arnica montana, carbomer copolymer type a, ceteth-10 phosphate, dihexadecyl phosphate, dimethyl sulfone, dimethyl sulfone, diethylene glycol monophenyl ether

Questions or comments?

Call toll-free 1.888.829.7165

Product label

image descriptionimage descriptionimage description

KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF 
methyl salicylate, menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0008
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
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)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
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:43493-0008-01 in 1 BOX01/30/2023
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:43493-0008-11 in 1 BOX01/30/2023
250 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:43493-0008-21 in 1 BOX01/30/2023
3119 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/07/2021
Labeler - Avaria Health & Beauty Corp (251366043)

Revised: 3/2023
Document Id: f76a47b0-a53f-765f-e053-6394a90a397c
Set id: 9b9b7cad-a5e2-4445-856b-4aa439d77a80
Version: 3
Effective Time: 20230321
 
Avaria Health & Beauty Corp