NITROVAL BLUE- menthol cream 
PLUM VALLEYPHARMA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NitroVal Blue cream

Drug facts

Active ingredients:

Menthol USP 3.7%

Purpose

Topical analgesic

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

Warnings

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

When using this product

Stop use and ask a doctor if

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

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.

Directions:

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

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

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

label

NITROVAL BLUE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82226-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82226-160-8585 g in 1 JAR; Type 0: Not a Combination Product06/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/21/2022
Labeler - PLUM VALLEYPHARMA LLC (118243219)

Revised: 6/2022
Document Id: b58fbd42-b6eb-431f-9412-1773841d80c6
Set id: bf40f3dd-5612-40e4-9fbf-8d306f75cedb
Version: 1
Effective Time: 20220621
 
PLUM VALLEYPHARMA LLC