FREE AND PURE COLD THERAPY PAIN RELIEF- menthol gel

Free and Pure Cold Therapy Pain Relief by

Drug Labeling and Warnings

Free and Pure Cold Therapy Pain Relief by is a Otc medication manufactured, distributed, or labeled by Walgreen Co., Natural Essentials, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joing associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

When using this product

• use only as directed
• avoid contact with the yes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritate skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

• you experience pain, swelling, or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

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

Directions

• adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a physician
• wash hands after use with cool water

Other information

• store at 20-25°C (68-77°F)
• store in a cool dry place away from direct sunlight

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia SErrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Silicon Dioxide, Tocopheryl Acetate, Water

Principal Display Panel - 8 fl oz

INGREDIENTS AND APPEARANCE

FREE AND PURE COLD THERAPY PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0383
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	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0383-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2025

Labeler - Walgreen Co. (008965063)

Registrant - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials, Inc.		947484713	manufacture(0363-0383)