Label: NOVARNICA FOOT PAIN RELIEVER- camphor and menthol spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 61871-005-01 - Packager: Xcentrik Inc.
- 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 December 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
-
Warnings
Allergy Alert: Do not use if allergic to Asteraceae or Compositae (daisy) family or to any other ingredient contained in this product.
- For external use only.
- Discontinue use if appearance of rash, irritation, reddening, dermatitis or eczema.
- Do not apply on wounds.
- Avoid contact with eyes and mucous membranes.
- Do not apply bandage or heat (heating pad) on the affected body part.
- Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding.
- Do not inhale or swallow.
- Directions
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NOVARNICA FOOT PAIN RELIEVER
camphor and menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61871-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8 g in 100 mL Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CLOVE OIL (UNII: 578389D6D0) EUCALYPTUS OIL (UNII: 2R04ONI662) ISOPROPYL ALCOHOL (UNII: ND2M416302) PEPPERMINT OIL (UNII: AV092KU4JH) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61871-005-01 1 in 1 CARTON 04/01/2015 1 65 mL in 1 BOTTLE; 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 04/01/2015 Labeler - Xcentrik Inc. (206906492)