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| NDC | 43493-0003-1, 43493-0003-2, 43493-0003-3 |
| Set ID | 60198d2e-4de3-3fa0-e053-2a91aa0afaf7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Avaria Health & Beauty Corp |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART348 |
- 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 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 (248926979)
