KALAYA EXTRA STRENGTH PAIN RELIEF CREAM WITH HEMP SEED OIL- methyl salicylate, menthol, camphor cream 
Avaria Health & Beauty Corp

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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 Cntrol 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

• If seal is broken, do not use

Inactive ingredients

Alcohol Denat., Arnica Montana Flower Extract, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Eucalyptus Globulus Leaf Oil, Cetearyl Alcohol, Hemp Seed Oil, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane, Oryza Sativa (Rice) Bran Oil, Sodium Hydroxide, Water

Questions or comments?

Call toll-free 1.888.829.7165

Product label

image descriptionimage description

KALAYA EXTRA STRENGTH PAIN RELIEF CREAM WITH HEMP SEED OIL 
methyl salicylate, menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0013
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
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
RICE BRAN OIL (UNII: LZO6K1506A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0013-01 in 1 CARTON12/01/2023
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/01/2023
Labeler - Avaria Health & Beauty Corp (251366043)
Establishment
NameAddressID/FEIBusiness Operations
Avaria Health & Beauty Corp251366043manufacture(43493-0013)

Revised: 11/2023
Document Id: 0ab0b0a3-55c9-2837-e063-6294a90a570d
Set id: 2eccf23c-fae2-423c-9cae-549bc4194104
Version: 1
Effective Time: 20231121
 
Avaria Health & Beauty Corp