Dendracin Neurodendraxcin®, Topical Pain Relief Lotion

Dendracin Neurodendraxcin®, Topical Pain Relief Lotion
SPL v12
SPL
SPL Set ID 05742cd5-ece2-4007-bdf0-46b76d23df74
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 g) Menthol (6 g) Capsaicin (0.015 g)
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 DRUG Active Since 2011-07-22

Description

Methyl Salicylate 30% Menthol 10% Capsaicin 0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

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 Physician’s Science and Nature Inc.



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

Warnings:

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

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 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:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Benzocaine, Borago Officinalis Seed Oil (Borage Oil), Cetyl Alcohol, Dimethyl Sulfoxide, DMDM Hydantoin, Glyceryl Stearate, Methylparaben, PEG 100 Stearate, Poloxamer 407, Propylene Glycol, Propylparaben, Lecithin (Soy), Stearic Acid, Sodium Stearoyl Glucamate, Triethanolamine, Water, Officinale Root Extract.

Principal Display Panel

Physician's Science and Nature Inc.

DENDRACIN



Neurodendraxcin®

Professional Formula



Dermatologically Tested



Hypoallergenic

Topical Pain Relief Lotion



Deep Penetrating Action

60 ml (2 fl oz)



NDC 27495-014-02

120 ml (4 fl oz)

NDC 27495-014-04

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.

Keep Away From Children and Pets.

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


Structured Label Content

Uses: (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 Physician’s Science and Nature Inc.



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

Purpose

Topical Analgesic

Warnings: (WARNINGS:)

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

Directions: (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 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 (ACTIVE INGREDIENTS)

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Benzocaine, Borago Officinalis Seed Oil (Borage Oil), Cetyl Alcohol, Dimethyl Sulfoxide, DMDM Hydantoin, Glyceryl Stearate, Methylparaben, PEG 100 Stearate, Poloxamer 407, Propylene Glycol, Propylparaben, Lecithin (Soy), Stearic Acid, Sodium Stearoyl Glucamate, Triethanolamine, Water, Officinale Root Extract.

Principal Display Panel

Physician's Science and Nature Inc.

DENDRACIN



Neurodendraxcin®

Professional Formula



Dermatologically Tested



Hypoallergenic

Topical Pain Relief Lotion



Deep Penetrating Action

60 ml (2 fl oz)



NDC 27495-014-02

120 ml (4 fl oz)

NDC 27495-014-04

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.

Keep Away From Children and Pets. (Keep away from children and pets.)

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


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