Label: KALAYA PAIN RELIEF 6X WITH ARNICA- pain relief cream cream
- NDC Code(s): 43493-0003-1, 43493-0003-2, 43493-0003-3
- Packager: Avaria Health & Beauty Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 21, 2022
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INGREDIENTS AND APPEARANCE
KALAYA PAIN RELIEF 6X WITH ARNICA
pain relief cream creamProduct 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 (251366043)
