Label: EB302 ARTHRITIS RELIEF- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 53304-0302-1 - Packager: EMINENCE BIOTECH CORPORATION LIMITED
- 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 20, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- on ears or nasal cavity
- if pregnant
- on wounds or damaged skin
- otherwise than as directed
When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50mL Bottle Carton
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INGREDIENTS AND APPEARANCE
EB302 ARTHRITIS RELIEF
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53304-0302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 865.4 mg in 50 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMARANTHUS VIRIDIS LEAF (UNII: 7T0WZ76K1T) PORK SIDE BACON, CURED FAT (UNII: 6E710H379S) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) GLYCERIN (UNII: PDC6A3C0OX) PLATOSTOMA PALUSTRE WHOLE (UNII: FE70D062O9) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53304-0302-1 1 in 1 BOX 11/01/2012 1 50 mL in 1 BOTTLE, SPRAY; 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 11/01/2012 Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)