KALAYA BACK AND NECK PAIN RELIEF- methyl salicylate, menthol, camphor liquid 
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 11%
Menthol 16%
Methyl salicylate 25%

Purpose

Topical Analgesic

Uses

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

Warnings

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

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

• Store at 59°F - 77°F

Inactive ingredients

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

Questions or comments?

Call toll-free 1.888.829.7165

Product label

image description

KALAYA BACK AND NECK PAIN RELIEF 
methyl salicylate, menthol, camphor liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)11 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0009-01 in 1 BOX02/16/2023
160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/16/2023
Labeler - Avaria Health & Beauty Corp (251366043)

Revised: 2/2023
Document Id: f4d3adb7-b88c-5262-e053-2995a90a7fd9
Set id: 48fd73e7-1443-4ac7-bf7c-d99bf2449f51
Version: 1
Effective Time: 20230216
 
Avaria Health & Beauty Corp