Label: EB301AP PAIN RELIEF- menthol spray
- NDC Code(s): 53304-0301-1, 53304-0301-3
- Packager: EMINENCE BIOTECH CORPORATION LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For the temporary relief of painClose
For external use only
When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if
- conditions worsen
- symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 12 years of age and over
Spray sufficient amount onto affected area to cover it completely, and rub until dry. Repeat no more than 3 to 4 times daily.
- Other information
Store at cool place (room temperature) away from heat and light sources.Close
- Inactive ingredients
Alcohol, Animal Fat, Euphorbia Hirta, Euphorbia Thymifolia Whole, Gaultheria Procumbens (Wintergreen) leaf Extract, Glycerin, WaterClose
- SPL UNCLASSIFIED SECTION
EMINENCE BIOTECH CORPORATION LIMITED
3411 SILVERSIDE ROAD, RODNEY BUILDING # 104Close
WILMINGTON DE19810 NEW CASTLE COUNTY, USA
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
PAIN RELIEVING SPRAY
3.38FL OZ (100mL)
- INGREDIENTS AND APPEARANCE
EB301AP PAIN RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53304-0301 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1000 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) EUPHORBIA HIRTA (UNII: L13YF113GN) PORK SIDE BACON, CURED FAT (UNII: 6E710H379S) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) GLYCERIN (UNII: PDC6A3C0OX) EUPHORBIA THYMIFOLIA WHOLE (UNII: D56Y3D2OTL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53304-0301-1 1 in 1 BOX 1 100 mL in 1 BOTTLE, SPRAY 2 NDC:53304-0301-3 1 in 1 BOX 2 15 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2013 Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)