NITROVAL BLUE- menthol cream

NitroVal Blue by

Drug Labeling and Warnings

NitroVal Blue by is a Otc medication manufactured, distributed, or labeled by PLUM VALLEYPHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

ACTIVE INGREDIENT

Active ingredients:

Menthol USP 3.7%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses Temporary relief from minor aches and pains of sore muscles & Joints associated with arthritis, simple backache, strains, bruises & sprains.

WARNINGS

Warnings

For external use only. Keep away from excessive hear or flame.

WHEN USING

When using this product

• Avoid contact with the eyes or mucous membranes not apply to wounds or damaged skin.
• Do not use with other ointments, creams, sprays, or liniments
• Do not apply to irritated skin or if excessive irritation develops
• Do not bandaged not use with heating pad or device
• Wash hands after use with cool water

STOP USE

Stop use and ask a doctor if

Condition worsens, or if symptoms persist for more than 7 days, or clear up and return.

KEEP OUT OF REACH OF CHILDREN

Warnings
If pregnant or breast-feeding: Ask a health professional before use.
Keep out of reach of children: If accidentally ingested, get medical
help or contact Poison Control Center immediately.
Other: Store in a cool dry place. Close cap tightly.

DOSAGE & ADMINISTRATION

Directions:

• Adults and children 12 years of age and older:
  Apply and massage onto affected areas. Repeat as needed no more
  than 4 times daily. Wash hands after use with cool water.
• Children under 12 years of age: Consult physician.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana
Flower Extract, Carbomer, Dimethyl Sulfone (MSM), EDTA, FDC Blue
#1, ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamin B6),
Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutyl parabens,
Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate,
Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured For:
Plum Valley Pharma, LLC
Dear born, MI 48120 USA
Questions and Information please call
Toll Free: 866-248-1553

PRINCIPAL DISPLAY PANEL

NDC: 82226-160-85                 For Topical Use Only

NitroValBLUE

Pain Relief Cream

Plum
Valley Pharma

Net Wt. 3 oz. (85g) Topical Analgesic

Made in USA

Manufactured For:
Plum Valley Pharma, LLC
Dear born, MI 48120 USA
Questions and Information please call
Toll Free: 866-248-1553

INGREDIENTS AND APPEARANCE

NITROVAL BLUE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82226-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TROLAMINE (UNII: 9O3K93S3TK)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82226-160-85	85 g in 1 JAR; Type 0: Not a Combination Product	06/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/21/2022

Labeler - PLUM VALLEYPHARMA LLC (118243219)