Otc - Active Ingredient
Active ingredients:
Menthol USP 3.7%
Nitroval Blue
FDA Label NDC 82226-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Plum Valleypharma Llc for the product Nitroval Blue (NDC 82226-160). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
Otc - 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.
Otc - 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
Other
Manufactured For:
Plum Valley Pharma, LLC
Dear born, MI 48120 USA
Questions and Information please call
Toll Free: 866-248-1553
Package Label.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
Label (Nitroval)
* Please review the disclaimer below.
