KALAYA EXTRA STRENGTH PAIN RELIEF GEL WITH ARNICA- methyl salicylate, menthol, camphor gel

Kalaya Extra Strength Pain Relief Gel with Arnica by

Drug Labeling and Warnings

Kalaya Extra Strength Pain Relief Gel with Arnica 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 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

• 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. 

KEEP OUT OF REACH OF CHILDREN

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., Aminomethyl propanol, Arnica Montana Flower Extract, Carbopol Ultrez 10, Cetearyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Polysorbate 80, Water

Questions or comments?

Call toll-free 1.888.829.7165

Product label

INGREDIENTS AND APPEARANCE

KALAYA EXTRA STRENGTH PAIN RELIEF GEL WITH ARNICA 
methyl salicylate, menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43493-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	11 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43493-0012-0	1 in 1 CARTON	12/01/2023
1		100 g in 1 TUBE; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Avaria Health & Beauty Corp		251366043	manufacture(43493-0012)