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 INGREDIENT

KEEP OUT OF REACH OF CHILDREN

PURPOSE

INACTIVE INGREDIENT

WARNINGS

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

Roller Ball PDP

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
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
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.5 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)
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: 43493-0003-1	120 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 43493-0003-2	50 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2018
3	NDC: 43493-0003-3	120 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2018

Labeler - Avaria Health & Beauty Corp (248926979)