Neuriterx
FDA Label NDC 72826-140

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Semprae Laboratories Inc for the product Neuriterx (NDC 72826-140). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin 0.05% 

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only

When Using This Product

• use only as directed
• do not bandage tightly
• do not use with heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight

Stop Use And Ask A Doctor If

  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 18 years:

  • Apply to affected area
  • Massage into painful area until thoroughly absorbed
  • Repeat as necessary, but no more than 3 to 4 times daily

    • Children 18 years or younger: ask a doctor

Other Information

Store at 20° - 25°C (68° - 77°F)
Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon
Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil,
Propylene Glycol, Sorbitol,Trolamine, Water

Package Label.Principal Display Panel

Image Description (Ne2000 U.s Carton V2.0 11 09 2020)

Image Description (Ne2000 U.s Carton V2.0 11 09 2020)

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