FDA.reportPublic FDA data

Icy Hot Pro Dry Spray

Manufacturer
Chattem, Inc.
Effective date
2023-03-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:29

Label at a glance#

ProductIcy Hot Pro Dry
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure7 sections

Dosage and administration

a dults and children 12 years of age and older : ▪ spray the affected area not more than 3 to 4 times daily ▪ product will dry quickly on its own, and does not need to be rubbed in ▪ wash hands thoroughly with soap and water after each use children under 12 years of age : ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ICY HOT PRO DRY SPRAY 

Drug Facts

Purpose

OTC - PURPOSE SECTION

Camphor 11%, Menthol 16%.............................................................................................................Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

■ arthritis     ■ simple backache     ■ strains  ■ sprains     ■ bruises                                

Warnings

WARNINGS SECTION

For external use only

Extremely flammable: keep away from fire, sparks, and heated surfaces. Contents under pressure, do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting.

Do not use

OTC - DO NOT USE SECTION

■ on wounds or on irritated or damaged skin

■ with a heating pad

When using this product

OTC - WHEN USING SECTION

■ use only as directed. Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes. Do not spray in face or mouth.

■ do not expose the area to local heat or direct sunlight

■ rare cases of serious burns have been reported with products of this type

■ a transient burning sensation may occur upon application but generally disappears in several days

■ avoid applying into skin folds

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ redness is present or excessive skin irritation occurs

■ you experience severe burning pain, swelling, or blistering where the product was applied

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older:
    ▪ spray the affected area not more than 3 to 4 times daily
    ▪ product will dry quickly on its own, and does not need to be rubbed in
    ▪ wash hands thoroughly with soap and water after each use
  • children under 12 years of age: ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol denat., glycerin, isobutane, propylene glycol, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT
PRO
Pain Relief
DRY SPRAY
NET WT 4 oz (113g)

PRINCIPAL DISPLAY PANEL ICY HOT PRO Pain Relief DRY SPRAY NET WT 4 oz (113g)PRINCIPAL DISPLAY PANEL ICY HOT PRO Pain Relief DRY SPRAY NET WT 4 oz (113g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1606046camphor 11 % / menthol 16 % Topical SprayPSN3
1606046camphor 110 MG/ML / menthol 160 MG/ML Topical SpraySCD3
1606046camphor 11 % / menthol 16 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0080-4Icy Hot Pro Dry118 mL in 1 CANSPRAY1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0080ICY HOT PRO DRY (CAMPHOR, MENTHOL) SPRAY [CHATTEM, INC.]3Current NDC, Legacy NDC, 1 package rows20250207_4de1bc29-d166-4599-9e75-5f841bf20967.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-008041167-0080-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
ndc (package): 41167-0080-4
ndc (product): 41167-0080
ndc11 (package): 41167008004
spl id: 86c31234-2223-4622-8c03-59e5cb1477b7
spl set id: 4de1bc29-d166-4599-9e75-5f841bf20967

Reported adverse events (FAERS/openFDA)#

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