NOVUM APR- menthol spray

NOVUM by

Drug Labeling and Warnings

NOVUM by is a Otc medication manufactured, distributed, or labeled by NOVUM SOLUTIONS INC, Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Topical Burn Cream Plus Pain Relief

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVUM  APR
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69574-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYL SALICYLATE (UNII: LAV5U5022Y)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SPEARMINT OIL (UNII: C3M81465G5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69574-005-05	1 in 1 BOX	05/19/2015
1	NDC: 69574-005-04	118.3 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/19/2015

Labeler - NOVUM SOLUTIONS INC (044818941)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(69574-005)