FDA.reportPublic FDA data

Overnight Cold Therapy Pain Relief

Manufacturer
Walgreen Co. | NATURAL ESSENTIALS, INC.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:34

Label at a glance#

ProductOvernight Cold Therapy Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

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: consult a physician wash hands after use with cool water

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: consult a physician
  • wash hands after use with cool water

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water

Principal Display Panel – 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

WALGREENS
PHARMACIST RECOMMENDED

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

OVERNIGHT
Cold Therapy
Pain Relief

MENTHOL 4%/TOPICAL ANALGESIC

Roll On

No Mess

  • For arthritis, back pain,
    sore muscles & joints
  • Soothing menthol
  • Paraben free

Lavender
scent

2.5 FL OZ (74 mL)

Principal Display Panel – 74 mL Bottle Label
Principal Display Panel – 74 mL Bottle Label

Principal Display Panel – 89 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

WALGREENS
PHARMACIST RECOMMENDED

Compare to the active ingredient
in Biofreeze® Overnight Gel††

OVERNIGHT
Cold
Therapy
Pain Relief
Gel

MENTHOL 4%/TOPICAL ANALGESIC

  • For arthritis, back pain,
    sore muscles & joints
  • Soothing menthol
  • Paraben free

Lavender
scent

3 FL OZ (89 mL)

Principal Display Panel – 89 mL Tube Label
Principal Display Panel – 89 mL Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0355-03Overnight Cold Therapy Pain Relief89 mL in 1 TUBEGEL892
0363-0355-25Overnight Cold Therapy Pain Relief74 mL in 1 BOTTLE, WITH APPLICATORGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0355OVERNIGHT COLD THERAPY PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [WALGREEN CO.]2Current NDC, 2 package rows20231216_2cbd0966-4cf9-4271-bd53-6672b1ed2a99.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-03550363-0355-25, 0363-0355-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
ndc (package): 0363-0355-25
ndc (package): 0363-0355-03
ndc (product): 0363-0355
ndc11 (package): 00363035525
ndc11 (package): 00363035503
spl id: 5f845434-d8db-4bfa-8fc0-8a9b9205f194
spl set id: 2cbd0966-4cf9-4271-bd53-6672b1ed2a99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.