ICY HOT KIDS PAIN RELIEF ROLL-ON- menthol liquid

Icy Hot Kids Pain Relief Roll-On by

Drug Labeling and Warnings

Icy Hot Kids Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot Kids Pain Relief Roll-On

Drug Facts

Active ingredient

Purpose

Menthol 4%.........................................................................................................................Topical analgesic

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

INGREDIENTS AND APPEARANCE

ICY HOT KIDS PAIN RELIEF ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0799
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0799-0	1 in 1 CARTON	01/15/2023
1		44.3 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/15/2023

Labeler - Chattem, Inc. (003336013)