Label: RS- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71798-003-03 - 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 7, 2019
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- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
RS
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71798-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 4 g in 4 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) WILLOW BARK (UNII: S883J9JDYX) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) PEPPERMINT OIL (UNII: AV092KU4JH) CANNABIDIOL (UNII: 19GBJ60SN5) EMU OIL (UNII: 344821WD61) METHYL SALICYLATE (UNII: LAV5U5022Y) CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) 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:71798-003-03 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 Pharmaceutical, LLC 080792350 manufacture(71798-003)