Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9926f733-1506-4224-9d70-b1813cd81ec3
Route
TOPICAL
Published
Effective Date 2024-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Camphor (synthetic) Cannabis Sativa Seed Oil Ethylhexylglycerin Fd&c Blue No. 1 Fd&c Yellow No. 5 Ilex Paraguariensis Leaf Isopropyl Alcohol Tea Tree Oil Dimethyl Sulfone Aloe Vera Leaf Arnica Montana Flower Phenoxyethanol Silicon Dioxide Sodium Chloride .alpha.-tocopherol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

Natural Menthol USP 10.0%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Natural Menthol USP 10.0%

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5

Children under 2 years old: Consult a physician

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
Other Information
  • Replace cap after use
  • Store in a cool, dry place
Active Ingredients

Natural Menthol USP 10.0%

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

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
Ask A Doctor Before Use If You
  • Have sensitive skin
  • Are pregnant or breastfeeding
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
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)


Structured Label Content

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5 (42229-5)

Children under 2 years old: Consult a physician

Purpose

Cooling Pain Relief

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
Do Not Use (Do not use)
  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin
Other Information (Other information)
  • Replace cap after use
  • Store in a cool, dry place
Active Ingredients

Natural Menthol USP 10.0%

Inactive Ingredients (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

When Using This Product (When using this product)
  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly
Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children. (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: (Adults/Children 2 years and older:)
  • Roll on the affected area not more than 3 or 4 times daily
  • Shake well before use
Principal Display Panel – 85 G Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)