Drug Facts
Topical Burn Cream Plus Pain Relief
Novum Spray
FDA Label NDC 69574-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Novum Solutions Inc for the product Novum (NDC 69574-005). 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 drug facts, active ingredient, purpose, indications, warnings, keep out of reach of children keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 0.5%
Purpose
Pain & Itch Relief
For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.
Indications
For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing.
Apply as often as needed.
Warnings
Not intended for use on children under 2 years old except as directed by a doctor.
Avoid contact with eyes.
For external use only.
If irritation develops and persists, discontinue use and consult a doctor.
If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
Keep Out Of Reach Of Children Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Directions
Apply this product topically to affected areas and allow to dry without rubbing.
Use as often as needed.
Use only as directed.
Other Information
External analgesic
Inactive Ingredients
ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.
Questions Or Comments
Novum Solutions, Inc.
1585 West Sam Houston Pkwy N, #820
Houston, TX 77403
www.NovumSolutions.com
CALL 832-200-8005
FAX 713-464-6319
Package Label.Principal Display Panel
Label (Novumapr)
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