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Icy Hot with Lidocaine Pain Relieving

Medically reviewed on March 26, 2018

Dosage form: cream
Ingredients: LIDOCAINE 0.4g in 1g, MENTHOL 0.1g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-1710

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.

Icy Hot Cream

ICY HOT®  with LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Active Ingredients

Lidocaine HCl 4%

Purposes

Topical anesthetic

Active Ingredients

Menthol 1 %

Purposes

Topical analgesic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do not use
  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product
  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several 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
  • you experience signs of skin injury, such as 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 and pets.

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 every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-21, water

Keep Carton As It Contains Important Information

Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

ICY HOT
Lidocaine
Plus Menthol
Pain Relieving Cream
Net Wt 1.75 OZ (49.6 g)

ICY HOT WITH LIDOCAINE  PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1710
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE0.4 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
ALOE VERA LEAF 
AMINOMETHYLPROPANOL 
CAPRYLYL TRISILOXANE 
CETOSTEARYL ALCOHOL 
CETETH-20 PHOSPHATE 
DIHEXADECYL PHOSPHATE 
DIMETHICONE 
EDETATE DISODIUM 
ETHYLHEXYLGLYCERIN 
GLYCERYL MONOSTEARATE 
ISOHEXADECANE 
METHYLPARABEN 
POLYSORBATE 60 
ALCOHOL 
STEARETH-21 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-1710-21 TUBE in 1 CARTON
149.6 g in 1 TUBE
2NDC:41167-1710-01 TUBE in 1 CARTON
276.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/01/2016
Labeler - Chattem, Inc. (003336013)

 
Chattem, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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