Label: NOVARNICA- camphor and menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61871-001-01, 61871-001-02 - 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
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- Active ingredients
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Warnings
- For external use only
- Avoid contact with eyes and mucous membranes
- Do not apply on wounds or damaged skin
- Do not bandage tightly
- Do not apply external heat such as an electric heating pad, as this may result in excessive skin irritation or skin burn
- Do not apply on or near the nipple
- If pregnant or breastfeeding, ask a health professional before use
- Do not inhale or swallow
- Allergy Alert: Do not use if allergic to Asteraceae/Compositae/Daisy family or to any other ingredient contained in this product
- Flammable: Keep away from fire or flame
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When using this product Rashes and/or burning discomfort have been known to occur; in which case discontinue use. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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INGREDIENTS AND APPEARANCE
NOVARNICA
camphor and menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61871-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 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:61871-001-01 1 in 1 CARTON 01/22/2014 1 65 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:61871-001-02 1 in 1 CARTON 01/22/2014 2 120 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 01/22/2014 Labeler - Xcentrik Inc. (206906492)