Neurosoothe Liquid
FDA Label NDC 85622-510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blue Heron Pharmaceuticals, Llc for the product Neurosoothe (NDC 85622-510). 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 active ingredients:, purposes:, uses:, directions:adults and children 2 years of age and older:, warnings:, stop use and ask doctor if:, keep out of reach of children, storage:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Camphor 3% & Menthol 3%

Purposes:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associated with:

  • Simple backache
  • Arthritis

Directions:Adults And Children 2 Years Of Age And Older:

Apply to affected area not more then 3 to 4 times daily.
Rub thoroughly until gel is absorbed.
For children under 2 years of age: Ask a doctor.

Warnings:

For external use ONLY. 

Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, aks a healthcare professional before use.

When using this product:

  • Avoid bandaging tightly
  • Avoid contact with eyes
  • Keep out of the reach of children

Stop Use And Ask Doctor If:

  • Condition worsens
  • Symptoms persist for more than 7 days

Keep Out Of Reach Of Children

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Storage:

  • Store at 68-77℉ (20-25℃) - Room Temperature
  • Do not exceed 100 oF (38 oC)

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Filipendula Ulmaria (Queen of the Prairie) Flower Extract, Glycerin, Hamamelis Virginiana (WitchHazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium
Carbonate, Yucca Schidigera Stem Extract.

* Please review the disclaimer below.