Neurodexx™ Pain Relief

Neurodexx™ Pain Relief
SPL v2
SPL
SPL Set ID c14e75d4-12ca-7527-e053-2995a90a0e16
Route
TOPICAL
Published
Effective Date 2021-05-01
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 NOT FINAL Active Since 2021-05-01

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: Rely Wellness

5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

Warnings:

For external use only. Do not use in eyes, mouth or 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 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/VP Copolymer, Zingiber Officinale Root Extract, Methylparaben, Propylparaben, Soy Lecithin, DMDM Hydantoin, Sodium Stearoyl Glutamate

Neurodexx™ Pain Relief

Hot Deep

Penetrating MAXIMUM STRENGTH

Topical Pain Relief Lotion

Provides Fast Temporary Relief from:

  • Arthritis pain
  • Muscular & Rheumetric pain
  • Joint pain & stifness



Doctor Recommended

  • Doctor Formulated
  • Dermatologically Tested Hypoallergenic

120 ml (4 fl oz)

NDC 81649-030-04

0.25gm (0.25 ml)

NDC 81649-030-25

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 Out of Reach of Children and Pets:

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


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: Rely Wellness

5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

Purpose

Topical Analgesic

Warnings:

For external use only. Do not use in eyes, mouth or 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 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 (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/VP Copolymer, Zingiber Officinale Root Extract, Methylparaben, Propylparaben, Soy Lecithin, DMDM Hydantoin, Sodium Stearoyl Glutamate

Neurodexx™ Pain Relief

Hot Deep

Penetrating MAXIMUM STRENGTH

Topical Pain Relief Lotion

Provides Fast Temporary Relief from:

  • Arthritis pain
  • Muscular & Rheumetric pain
  • Joint pain & stifness



Doctor Recommended

  • Doctor Formulated
  • Dermatologically Tested Hypoallergenic

120 ml (4 fl oz)

NDC 81649-030-04

0.25gm (0.25 ml)

NDC 81649-030-25

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 Out of Reach of Children and Pets: (Keep Out Of Reach Of Children And Pets:)

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


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