Numotizine Ointment

Numotizine Ointment
SPL v8
SPL
SPL Set ID 9a29ad1b-4ba3-403f-90c9-ee7582fe4535
Route
TOPICAL
Published
Effective Date 2019-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Kaolin Guaiacol Creosol Methyl Salicylate Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-30

Description

Menthol 1.25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.25%

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

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.

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.

Package Labeling:

Active Ingredients

Menthol 1.25%

Numotizine Ointment



Inactive Ingredients

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

Stop Use and Ask A Doctor If
  • Excessive irritation of the skin occurs.
  • Persistent swellings.

Keep Out of the Reach of Children



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









Structured Label Content

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

Purpose

Topical Analgesic

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.

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.

Package Labeling:

Active Ingredients

Menthol 1.25%

Numotizine Ointment (NUMOTIZINE OINTMENT)



Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Excessive irritation of the skin occurs.
  • Persistent swellings.

Keep Out of the Reach of Children (Keep out of the reach of children)



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









Advanced Ingredient Data


Raw Label Data

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