COLD THERAPY PAIN RELIEF- menthol, unspecified form gel 
Walgreen Co.

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Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical Analgesic

Uses

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

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 eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated 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 oi 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

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

Principal Display Panel – 74 mL Bottle Label

Walgreens

Compare to the active ingredient
in Biofreeze
® Roll-On††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy
Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

2.5 FL OZ (74 ml)

Principal Display Panel – 74 mL Bottle Label

Principal Display Panel – 89 mL Tube Label

Walgreens

Compare to the active
ingredient in Biofreeze® Gel
††

WALGREENS PHARMACIST RECOMMENDED

Cold
Therapy
Pain Relief
Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

3 FL OZ (89 ml)

Principal Display Panel – 89 mL Tube Label
COLD THERAPY PAIN RELIEF 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0356
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM36 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0356-2574 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2024
2NDC:0363-0356-0389 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/01/2024
Labeler - Walgreen Co. (008965063)
Registrant - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(0363-0356)

Revised: 4/2024
Document Id: f2ea3545-6938-4a13-8969-32f38f3d9fff
Set id: ede15818-5d17-477d-a8be-7b36bb0770a6
Version: 1
Effective Time: 20240422
 
Walgreen Co.