Octagon Pain Relief Gel
FDA Label NDC 66902-196

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Octagon Pain Relief (NDC 66902-196). 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, do not use, ask a doctor before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Natural Menthol USP 10.0%

Purpose

Cooling Pain Relief

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Sprains

Warnings

  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame

Do Not Use

  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin

Ask A Doctor Before Use If You

  • Have sensitive skin
  • Are pregnant or breastfeeding

When Using This Product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops

Keep Out Of Reach Of Children.

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

Adults/Children 2 Years And Older:

  • Roll on the affected area not more than 3 or 4 times daily
  • Shake well before use

Other

Children under 2 years old: Consult a physician

Other Information

  • Replace cap after use
  • Store in a cool, dry place

Inactive Ingredients

Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Arnica Montana (Arnica Flower) Extract, Camphor, Cannabis Sativa Seed Oil, Dead Sea Salts, Ethylhexylglycerin, FD&C Blue #1, FD&C Yellow #5, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Methylsulfonylmethane USP, Phenoxyethanol, Silicon Dioxide, Tocopheryl Acetate, Triethanolamine, Water.

Questions & Comments:

octagongel.com

Manufactured in USA
Exclusively Manufactured For:
Extreme Relief LLC
1967 E Maple St Ste 181
North Canton OH 44720

Principal Display Panel – 85 G Bottle Label

OCTAGON
PAIN RELIEF

EXTREME FORMULA

FOR THE TEMPORARY RELIEF OF
JOINT PAIN BACK PAIN
ARTHRITIS MUSCLE PAIN

Net wt 3 oz (85g)

Figure (Oct08 0000 01)

Figure (Oct08 0000 01)

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