ICY HOT ADVANCED RELIEF- camphor (synthetic) and menthol cream 
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Icy Hot Advanced Relief Cream

Drug Facts

Active ingredients

Menthol 16%

Camphor 11%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad, or medicated patch
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears within a few days 

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant of 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 over 12 years:

Children 12 years and younger: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer,  allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)

Principal Display Panel

ICY HOT®
ADVANCED RELIEF
PAIN RELIEF CREAM
Net WT 2 OZ (56 g)

ICY HOT®
ADVANCED RELIEF
PAIN RELIEF CREAM
Net WT 2 OZ (56 g)

ICY HOT ADVANCED RELIEF 
camphor and menthol cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0801
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.11 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
CETYL ALCOHOL 
DIISOPROPYL ADIPATE 
EDETATE DISODIUM 
DIETHYLENE GLYCOL MONOETHYL ETHER 
GLYCERIN 
GLYCERYL MONOSTEARATE 
MENTHYL LACTATE, (-)- 
METHYLPARABEN 
PEG-150 STEARATE 
PENTYLENE GLYCOL 
4-TERT-BUTYLCYCLOHEXANOL 
PHENOXYETHANOL 
POLYSORBATE 80 
PROPANEDIOL 
SOY STEROL 
STEARETH-21 
STEARIC ACID 
TROLAMINE 
WATER 
XANTHAN GUM 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0801-01 in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2012
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 2830410721ANALYSIS(41167-0801), LABEL(41167-0801), MANUFACTURE(41167-0801), PACK(41167-0801), RECOVERY(41167-0801), RELABEL(41167-0801), REPACK(41167-0801)

Revised: 3/2013
Document Id: 5f4db1da-f3e6-4524-a713-1332e629508d
Set id: 9979ff36-415b-44e4-bb10-6bf682cd00f9
Version: 1
Effective Time: 20130326
 
Chattem, Inc.