NUMOTIZINE - menthol ointment 
Hobart Laboratories, Inc.

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.

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NUMOTIZINE OINTMENT

NUMOTIZINE OINTMENT


Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Inactive ingredients

Clay, Color, Fragrance of Guaiacol, Methyl Guaiacol and Oil of Wintergreen, Polyols.

Directions

Stir in any liquid at top of jar. Keep sealed when not in use.

Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.

Uses

For use as a topical analgesic

Stop use and ask a doctor if

Keep out of the reach of children


Warnings:

For external use only.

Use only as directed. Avoid contact with eyes and mucous memebranes.

Do not apply to irritated or broken skin or to large areas of the body.

Representative Labeling For - Numotizine Ointment 3.5oz/99g (10546-100-35) | Numotizine Ointment 8oz/228g (10546-100-08)


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Package Labeling:

LabelLabel2

NUMOTIZINE  
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10546-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
GUAIACOL (UNII: 6JKA7MAH9C)  
CREOSOL (UNII: W9GW1KZG6N)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10546-100-3599 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
2NDC:10546-100-08228 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/30/2011
Labeler - Hobart Laboratories, Inc. (005111786)
Registrant - Hobart Laboratories, Inc. (005111786)
Establishment
NameAddressID/FEIBusiness Operations
Hobart Laboratories, Inc.005111786manufacture(10546-100)

Revised: 9/2019
Document Id: 92acc611-a1dc-93a7-e053-2a95a90aca4a
Set id: 9a29ad1b-4ba3-403f-90c9-ee7582fe4535
Version: 6
Effective Time: 20190916
 
Hobart Laboratories, Inc.