Label: PS- menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 71798-005-03 - 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 January 25, 2020
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INGREDIENTS AND APPEARANCE
PS
menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71798-005 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 16 g in 16 mg Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) BLACK PEPPER OIL (UNII: U17J84S19Z) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) ALOE VERA LEAF (UNII: ZY81Z83H0X) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71798-005-03 88.7 mg in 1 JAR; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2020 Labeler - New Leaf Pharmaceutical, LLC (080792350) Establishment Name Address ID/FEI Business Operations New Leaf Pharmaceutical, LLC 080792350 manufacture(71798-005)
