Numotizine Ointment
FDA Label NDC 10546-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hobart Laboratories, Inc. for the product Numotizine (NDC 10546-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding numotizine ointment, active ingredients, purpose, inactive ingredients, directions, uses, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Numotizine8 (Numotizine8)
Numotizinecarton (Numotizinecarton)
Numotizinecartona (Numotizinecartona)
* Please review the disclaimer below.
