ICY HOT ADVANCED RELIEF- camphor and menthol cream

Icy Hot Advanced Relief by

Drug Labeling and Warnings

Icy Hot Advanced Relief by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16%

Camphor 11%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

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:

• apply a thin layer to affected area
  
• message into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
  
• AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

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)

INGREDIENTS AND APPEARANCE

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

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 (55000 CPS) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0801-0	1 in 1 CARTON	12/01/2012
1		56 g in 1 TUBE; Type 0: Not a Combination Product

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)