FDA.reportPublic FDA data

Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil

Manufacturer
Avaria Health & Beauty Corp
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:28

Label at a glance#

ProductKalaya Extra Strength Pain Relief Cream with Hemp Seed Oil
Active ingredientMETHYL SALICYLATE, LEVOMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%
Menthol 4%
Methyl salicylate 11%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only


Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children under 12 years of age with arthritis-like conditions

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor

  • condition worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Cntrol Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

• Store at 59°F - 77°F

• If seal is broken, do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

SPL UNCLASSIFIED SECTION

Call toll-free 1.888.829.7165

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0013-0Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil60 g in 1 TUBECREAM603
43493-0013-0Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil1 in 1 CARTONCREAM13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43493-001343493-0013-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
EUCALYPTUS OIL2R04ONI662IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
RICE BRAN OILLZO6K1506AIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
METHYL SALICYLATELAV5U5022YACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-19full-release2026-06-01 00:38:02

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
ndc (package): 43493-0013-0
ndc (product): 43493-0013
ndc11 (package): 43493001300
spl id: 40a7f089-71e7-6c46-e063-6294a90ade99
spl set id: 2eccf23c-fae2-423c-9cae-549bc4194104

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.