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NUMOTIZINE

Medically reviewed on June 5, 2018

Dosage form: ointment
Ingredients: MENTHOL 1.25g in 100g
Labeler: Hobart Laboratories, Inc.
NDC Code: 10546-100

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.

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

  • Provides temporary relief of muscle pain, soreness and stiffness
  • Temporary pain relief on strains, sprains, ligament and tendon injuries
  • Arthritis

Stop use and ask a doctor if
  • Excessive irritation of the skin occurs.
  • Persistent swellings.

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)




NUMOTIZINE  
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10546-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN 
GUAIACOL 
CREOSOL 
METHYL SALICYLATE 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:10546-100-3599 g in 1 JAR
2NDC:10546-100-08228 g in 1 JAR
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/FEIOperations
Hobart Laboratories, Inc.005111786manufacture(10546-100)

Document Id: d4255df9-25b6-4373-9b04-827605029434
Set id: 9a29ad1b-4ba3-403f-90c9-ee7582fe4535
Version: 4
Effective Time: 20130605
 
Hobart Laboratories, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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