Label: KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF- methyl salicylate, menthol, camphor cream
- NDC Code(s): 43493-0008-0, 43493-0008-1, 43493-0008-2
- 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 March 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
-
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 CHILDRENif swallowed get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Product label
-
INGREDIENTS AND APPEARANCE
KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF
methyl salicylate, menthol, camphor creamProduct 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)