Label: PROF- mentholxs spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71798-004-03 - Packager: New Leaf Pharmaceutical, LLC
- 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 October 16, 2019
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- ACTIVE INGREDIENT
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
PROF
mentholxs sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71798-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10.5 g in 10.5 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WILLOW BARK (UNII: S883J9JDYX) PEPPERMINT OIL (UNII: AV092KU4JH) CANNABIDIOL (UNII: 19GBJ60SN5) EMU OIL (UNII: 344821WD61) METHYL SALICYLATE (UNII: LAV5U5022Y) Product Characteristics Color white (Solution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71798-004-03 88.7 mL in 1 CAN; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2019 Labeler - New Leaf Pharmaceutical, LLC (080792350) Establishment Name Address ID/FEI Business Operations New Leaf Pharmaceuticals, LLC 080792350 manufacture(71798-004)
