KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF- methyl salicylate, menthol, camphor cream

KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief by

Drug Labeling and Warnings

KALAYA PAIN RELIEF 6X WITH ARNICA - 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 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
• do not point towards face while squeezing

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 Control 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

Inactive ingredients

water, rice bran oil, cetyl alcohol, isopropyl palmitate, sodium hydroxide, glycerin, eucalyptus oil, arnica montana, carbomer copolymer type a, ceteth-10 phosphate, dihexadecyl phosphate, dimethyl sulfone, dimethyl sulfone, diethylene glycol monophenyl ether

Questions or comments?

Call toll-free 1.888.829.7165

Product label

INGREDIENTS AND APPEARANCE

KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF 
methyl salicylate, menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43493-0008
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
RICE BRAN OIL (UNII: LZO6K1506A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ARNICA MONTANA (UNII: O80TY208ZW)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
DIETHYLENE GLYCOL MONOPHENYL ETHER (UNII: LZU6ET206Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43493-0008-0	1 in 1 BOX	01/30/2023
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43493-0008-1	1 in 1 BOX	01/30/2023
2		50 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 43493-0008-2	1 in 1 BOX	01/30/2023
3		119 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/07/2021

Labeler - Avaria Health & Beauty Corp (251366043)