OCTAGON PAIN RELIEF- menthol, unspecified form gel

Octagon Pain Relief by

Drug Labeling and Warnings

Octagon Pain Relief by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Directions

Adults/Children 2 years and older:

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

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)

INGREDIENTS AND APPEARANCE

OCTAGON PAIN RELIEF 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-196
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-196-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/08/2024

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-196)