ICY HOT ORIGINAL NIGHTTIME RECOVERY PAIN RELIEF NO MESS ROLL ON- menthol liquid

Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On by

Drug Labeling and Warnings

Icy Hot Original Nighttime Recovery Pain Relief No Mess 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 Original Nighttime Recovery Pain Relief No Mess Roll On

Drug Facts

Active ingredient

Menthol 8%

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

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

■ 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

INGREDIENTS AND APPEARANCE

ICY HOT ORIGINAL NIGHTTIME RECOVERY PAIN RELIEF NO MESS ROLL ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ALLANTOIN (UNII: 344S277G0Z)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARETH-2 (UNII: V56DFE46J5)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1709-0	1 in 1 CARTON	01/03/2025
1		59 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	01/03/2025

Labeler - Chattem, Inc. (003336013)