KALAYA PAIN RELIEF 6X WITH ARNICA- pain relief cream cream

Kalaya Pain Relief 6X with Arnica by

Drug Labeling and Warnings

Kalaya Pain Relief 6X 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]

Active Ingredients

Camphor 4%

Menthol 4%

Methyl Salicylate 11%

Purpose

Camphor 4% Topical Analgesic

Menthol 4% Topical Analgesic

Methyl Salicylate 11% Topical Analgesic

Uses

Penetrating pain rub for the temporary relief of minor muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Warnings

• For external use only

Do Not Use

• on wounds or damage 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 on mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens 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

• KEEP OUT OF THE REACH OF CHILDREN

Other information

• Store at 59 oF – 77 oF
• If seal is broken, do not use

Directions

• Adults and children 12 years and over: Use no more than 3 to 4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Inactive ingredients

Arnica Montana, Carbomer, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Oryza Sative (Rice) Bran Oil, Phenoxyethanol, Purified Water, Sodium Hydroxide

Qustions or comments?

Call toll-free 1.888.829.7165

Principle Display Panel - 0.35oz (10 gm) sample pouch

INGREDIENTS AND APPEARANCE

KALAYA PAIN RELIEF 6X WITH ARNICA 
pain relief cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43493-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	11 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
RICE BRAN OIL (UNII: LZO6K1506A)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA (UNII: O80TY208ZW)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43493-0003-4	10 g in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - Avaria Health & Beauty Corp. (248926979)