Active Ingredients
Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%
Dendracin Neurodendraxcin
FDA Label NDC 52959-930
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Dendracin Neurodendraxcin (NDC 52959-930). 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, purpose, uses:, warnings:, directions:, do not use:, stop use and ask a physician:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.
Warnings:
For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products.
Directions:
Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.
Do Not Use:
On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa.
Store below 90°F/32°C.
Stop Use And Ask A Physician:
For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.
Inactive Ingredients:
Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin, sodium stearoyl glutamate.
Other
Manufactured for Physicians' Science and Nature, Inc.
220 Newport Center Drive 11-634, Newport Beach, CA 92660
Relabeled by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444
Made in the USA
Patent Pending
Principal Display Panel
Physicians' Science and Nature Inc.
Dendracin
Neurodendraxcin®
New Formula
Professional Formula
Topical Pain Relief Lotion
Deep Penetrating Action
120 ml (4 fl oz)
NDC 27495-014-04
4 Oz Label (05742cd5 Ece2 4007 Bdf0 46b76d23df74 01)
* Please review the disclaimer below.
