Label: NUMOTIZINE- menthol ointment
- NDC Code(s): 10546-100-08, 10546-100-35
- Packager: Hobart Laboratories, 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 September 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- NUMOTIZINE OINTMENT
- Active Ingredients
- Purpose
- Inactive ingredients
- Directions
- Uses
- Stop use and ask a doctor if
- Keep out of the reach of children
- Warnings:
- Representative Labeling For - Numotizine Ointment 3.5oz/99g (10546-100-35) | Numotizine Ointment 8oz/228g (10546-100-08)
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
NUMOTIZINE
menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10546-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) GUAIACOL (UNII: 6JKA7MAH9C) CREOSOL (UNII: W9GW1KZG6N) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10546-100-35 99 g in 1 JAR; Type 0: Not a Combination Product 11/30/2011 2 NDC:10546-100-08 228 g in 1 JAR; Type 0: Not a Combination Product 11/30/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/30/2011 Labeler - Hobart Laboratories, Inc. (005111786) Registrant - Hobart Laboratories, Inc. (005111786) Establishment Name Address ID/FEI Business Operations Hobart Laboratories, Inc. 005111786 manufacture(10546-100)