FDA.reportPublic FDA data

KALAYA BACK AND NECK PAIN RELIEF

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 01:38:31

Label at a glance#

ProductKALAYA BACK AND NECK PAIN RELIEF
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

Dosage and administration

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 11%
Menthol 16%
Methyl salicylate 25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For External Use Only. Flammable. Keep away from heat or flame.


Do not use:
• on wounds or damaged skin
• with a heating pad
• on a child 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 if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days and/or excessive skin irritation occurs.


Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and

allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.

Other information

SPL UNCLASSIFIED SECTION

• Store at 59°F - 77°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Mentha Piperita (Peppermint) Oil

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll-free 1.888.829.7165

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2629985camphor 11 % / menthol 16 % / methyl salicylate 25 % Topical SprayPSN3
2629985camphor 110 MG/ML / menthol 160 MG/ML / methyl salicylate 250 MG/ML Topical SpraySCD3
2629985camphor 11 % / menthol 16 % / methyl salicylate 25 % Topical SpraySY3

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
43493-0009-0KALAYA BACK AND NECK PAIN RELIEF60 mL in 1 BOTTLE, SPRAYLIQUID603
43493-0009-0KALAYA BACK AND NECK PAIN RELIEF1 in 1 BOXLIQUID13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43493-000943493-0009-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-19full-release2026-06-01 00:38:03

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 BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
ndc (package): 43493-0009-0
ndc (product): 43493-0009
ndc11 (package): 43493000900
spl id: 40a7f974-d0c4-986a-e063-6294a90abd29
spl set id: 48fd73e7-1443-4ac7-bf7c-d99bf2449f51

Reported adverse events (FAERS/openFDA)#

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