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 Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0801
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.11 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.16 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPANEDIOL (UNII: 5965N8W85T)  
SOY STEROL (UNII: PL360EPO9J)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41167-0801-0 1 in 1 CARTON
1 56 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 12/01/2012
Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 2 830410721 ANALYSIS(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.