Icy Hot Arthritis Lotion

Drug Labeling and Warnings

Drug Details [pdf]

ICY HOT ARTHRITIS- camphor and menthol lotion 
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 Arthritis Lotion

Drug Facts

Active ingredients

Camphor 4%

Menthol 16%

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
  
• 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 several days
  
• if severe burning sensation occurs, discontinue use immediately
  
• do not expose the area treated with product to heat or direct sunlight

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

Flammable

• keep away from fire or flame

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 over 12 years of age:

• apply generously to affected area
  
• massage into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but no more than 3-4 times daily
  
• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND COOL WATER

children 12 years of age or younger: ask a doctor

Inactive ingredients

acrylates/C10-C30 alkyl acrylate crosspolymer, capsaicin, cetyl alcohol, citric acid, diisopropyl adipate, disodium EDTA, ethoxydiglycol, glycerin, glyceryl dilaurate, glyceryl stearate, glycine soja sterols, menthyl lactate, methylparaben, PEG-150 stearate, phenoxyethanol, polysorbate 80, propylene glycol, SD alcohol 40 (15% w/w), steareth-2, steareth-21, tocopheryl acetate, triethanolamine, water, xanthan gum (283-106)

PRINCIPAL DISPLAY PANEL

NEW! ICY HOT ARTHRITIS pain relief lotion
RELIEVES PAINFUL FLARE-UPS
Long Lasting Formula
Safe for use with Oral Medications
Micro Encapsulated Menthol
NET WT 5.5 OZ (155 g)

ICY HOT ARTHRITIS 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0085-6	155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/17/2011	03/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/17/2011	03/31/2016

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-0085) , MANUFACTURE(41167-0085) , PACK(41167-0085)

Revised: 3/2016

Document Id: ae2f6fe2-a097-4d97-8455-14d8f3e9faa0

34390-5

Set id: 88c19a70-0739-4b18-832d-3ead1b133ba6

Version: 3

Effective Time: 20160331