Label: KASEHA PAIN RELIEVING GEL- camphor, capsaicin, menthol, methyl salicylate gel
- NDC Code(s): 83056-001-04
- Packager: Denali Natural Products
- 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 May 1, 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
- Use
-
Warnings
For external use only.
When using this product • avoid contact with the eyes and mucous membranes
- do not apply to wounds or damaged skin • do not bandage tightly
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KASEHA PAIN RELIEVING GEL
camphor, capsaicin, menthol, methyl salicylate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83056-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3.2 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.15 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) ALOE VERA LEAF (UNII: ZY81Z83H0X) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) GUAIACUM OFFICINALE WOOD (UNII: 51EUI60BAN) TROLAMINE (UNII: 9O3K93S3TK) GUAIACUM OFFICINALE WOOD OIL (UNII: D1S7X78492) ROSEMARY OIL (UNII: 8LGU7VM393) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83056-001-04 120 mL in 1 JAR; Type 0: Not a Combination Product 04/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/07/2023 Labeler - Denali Natural Products (118803692)