KALAYA BACK AND NECK PAIN RELIEF- methyl salicylate, menthol, camphor liquid

KALAYA BACK AND NECK PAIN RELIEF by

Drug Labeling and Warnings

KALAYA BACK AND NECK PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Avaria Health & Beauty Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

KALAYA BACK AND NECK PAIN RELIEF 
methyl salicylate, menthol, camphor liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43493-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43493-0009-0	1 in 1 BOX	02/16/2023
1		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/16/2023

Labeler - Avaria Health & Beauty Corp (251366043)