Active Ingredient
Menthol 8%
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On Liquid
FDA Label NDC 41167-1709
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On (NDC 41167-1709). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
temporarily relieves minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises
Warnings
For external use only
Do Not Use
■ on wounds or on irritated or damaged skin
■ with a heating pad
When Using This Product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ do not expose the area to local heat or to 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
■ 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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ adults and children 12 years of age and older:
■ apply a thin layer to affected area not more than 3 to 4 times daily
■ massage until thoroughly absorbed into skin
■ wash hands thoroughly with soap and water after each use
■ children under 12 years of age: ask a doctor
Inactive Ingredients
water, glycerin, propanediol, diisopropyl adipate, aloe barbadensis leaf juice, fragrance, steareth-21, acrylates/C10-30 alkyl acrylate crosspolymer, hydroxyacetophenone, allantoin, potassium hydroxide, ethylhexylglycerin, steareth-2
Principal Display Panel
ICYHOT
ORIGINAL
NIGHTTIME RECOVERY
PAIN RELIEF
NO-MESS
ROLL ON
Principal Display Panelicyhotoriginalnighttime Recoverypain Reliefno-messroll On (Icy Hot Original Nighttime Recovery Pain Relief No 01)
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