- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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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.
- Directions
- Other information
- Inactive ingredients
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- Principal Display Panel
- PRINCIPAL DISPLAY PANEL
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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)