Dendracin Neurodendraxcin®, Topical Pain Relief Lotion

Dendracin Neurodendraxcin®, Topical Pain Relief Lotion
SPL v25
SPL
SPL Set ID b36c7977-557d-4ab4-bc4a-35875f1848e6
Route
TOPICAL
Published
Effective Date 2018-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (300 mg) Menthol (100 mg) Capsaicin (0.25 mg)
Inactive Ingredients
Water Benzocaine Glyceryl Monostearate Peg-100 Stearate Stearic Acid Propylene Glycol Cetyl Alcohol Dimethyl Sulfoxide Poloxamer 407 Aloe Vera Leaf Borage Seed Oil Ammonio Methacrylate Copolymer Type A Ginger Lecithin, Soybean Methylparaben Propylparaben Dmdm Hydantoin Sodium Stearoyl Glutamate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-07-22

Description

Methyl Salicylate 30% Menthol 10% Capsaicin 0.025%

Purpose

Topical Analgesic

How Supplied

Product: 50436-0165 NDC: 50436-0165-1 120 mL in a BOTTLE


Medication Information

Purpose

Topical Analgesic

How Supplied

Product: 50436-0165

NDC: 50436-0165-1 120 mL in a BOTTLE

Description

Methyl Salicylate 30% Menthol 10% Capsaicin 0.025%

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Section 42229-5

Manufactured for Physicians' Science and Nature, Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Made in the USA

Patent Pending

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.

Active Ingredients

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

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.

Dendracin Topical Pain Relief
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.


Structured Label Content

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Section 42229-5 (42229-5)

Manufactured for Physicians' Science and Nature, Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Made in the USA

Patent Pending

Purpose

Topical Analgesic

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.

How Supplied (HOW SUPPLIED)

Product: 50436-0165

NDC: 50436-0165-1 120 mL in a BOTTLE

Active Ingredients (Active ingredients)

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Inactive Ingredients: (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.

Dendracin Topical Pain Relief (DENDRACIN TOPICAL PAIN RELIEF)
Stop Use and Ask A Physician: (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.


Advanced Ingredient Data


Raw Label Data

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