Purpose
Menthol 4%.........................................................................................................................Topical analgesic
Icy Hot Kids Pain Relief Roll-on
FDA Label NDC 41167-0799
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 Kids Pain Relief Roll-on (NDC 41167-0799). 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 purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Uses
temporarily relieves minor aches and pains of muscles and joints associated with: ■ strains
■ sprains ■ bruises ■ simple backache
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
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
■ children 2 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 2 years of age: ask a doctor
Inactive Ingredients
allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water
PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION. Close cap tightly after use.
Keep carton as it contains important information.
Principal Display Panel
Icy Hot
Kids Pain Relief
Roll-On
1.5 FL OZ (44.3 mL) ROLL-ON
Principal Display Panelicy Hot Kids Pain Relief Roll-on1.5 Fl Oz (44.3 mL) Roll-on (Icy Hot Kids Pain Relief Roll On 01)
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