- Drug Facts
- Active Ingredient
- Purpose
- Indications
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Warnings
Not intended for use on children under 2 years old except as directed by a doctor.
Avoid contact with eyes.
For external use only.
If irritation develops and persists, discontinue use and consult a doctor.
If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor. - KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NOVUM APR
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69574-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYL SALICYLATE (UNII: LAV5U5022Y) EUCALYPTUS OIL (UNII: 2R04ONI662) SPEARMINT OIL (UNII: C3M81465G5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69574-005-05 1 in 1 BOX 05/19/2015 1 NDC:69574-005-04 118.3 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 05/19/2015 Labeler - NOVUM SOLUTIONS INC (044818941) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(69574-005)