NUMOTIZINE- menthol ointment

NUMOTIZINE by

Drug Labeling and Warnings

NUMOTIZINE by is a Otc medication manufactured, distributed, or labeled by Hobart Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Package Labeling:

INGREDIENTS AND APPEARANCE

NUMOTIZINE  
menthol ointment

Product 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)