Label: ICY HOT MEDICATED NO MESS APPLICATOR- Menthol Liquid

Label: ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

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• NDC Code(s): 41167-0091-0, 41167-0091-1, 41167-0091-2
• Packager: Chattem, Inc.

• Category: HUMAN OTC DRUG LABEL
• DEA Schedule: None

Drug Label Information

Updated February 1, 2025

If you are a consumer or patient please visit this version.

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• SPL UNCLASSIFIED SECTION

  Icy Hot® - Medicated No Mess Applicator

• Active ingredient

  Menthol 16%

• Purpose

  Topical analgesic

• Uses

  temporarily relieves minor pain associated with:  

  • arthritis
  • simple backache  
  • strains  
  • sprains  
  • bruises  
• Warnings

  For external use only

  Flammable: keep away from heat and open flame.

  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

  acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (30%), capsaicin, glycerin, isopropyl myristate, propylene glycol, triethanolamine, water

  Close cap tightly after use.

• Principal Display Panel

  ICY HOT®  

  ORIGINAL NO-MESS ROLL ON PAIN RELIEF  16% MENTHOL

  2.5 fl oz (73 mL) 

  

• INGREDIENTS AND APPEARANCE

  ICY HOT MEDICATED NO MESS APPLICATOR  menthol liquid

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0091 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.16 g  in 1 mL

  Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)   ALCOHOL (UNII: 3K9958V90M)   CAPSAICIN (UNII: S07O44R1ZM)   GLYCERIN (UNII: PDC6A3C0OX)   ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   TROLAMINE (UNII: 9O3K93S3TK)   WATER (UNII: 059QF0KO0R)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0091-0 1 in 1 CARTON 12/01/2009 1 73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 2 NDC:41167-0091-1 1 in 1 CARTON 01/01/2021 2 44.3 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 3 NDC:41167-0091-2 3 in 1 BLISTER PACK 01/01/2022 3 73 mL in 1 BOTTLE, WITH APPLICATOR; 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 12/01/2009

  Labeler - Chattem, Inc. (003336013)

  Establishment
  Name	Address	ID/FEI	Business Operations
  CHATTEM, INC.	830410721	label(41167-0091) , manufacture(41167-0091) , pack(41167-0091)

  Establishment
  Name	Address	ID/FEI	Business Operations
  CHATTEM, INC.	003336013	analysis(41167-0091) , label(41167-0091) , manufacture(41167-0091) , pack(41167-0091)

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Safety

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Related Resources

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More Info on this Drug

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ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

Number of versions: 6

Published Date (What is this?)	Version	Files
Feb 26, 2025	7 (current)	download
Oct 31, 2023	5	download
Mar 30, 2021	4	download
Sep 22, 2020	3	download
Nov 14, 2018	2	download
Oct 9, 2010	1	download

ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

RxCUI	RxNorm NAME	RxTTY
1	866084	menthol 16 % Topical Solution	PSN
2	866084	menthol 160 MG/ML Topical Solution	SCD
3	866084	menthol 16 % Topical Solution	SY

ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

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ICY HOT MEDICATED NO MESS APPLICATOR- menthol liquid

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1	41167-0091-0
2	41167-0091-1
3	41167-0091-2

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