Icy Hot With Lidocaine Cream
FDA Label NDC 41167-1710

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot With Lidocaine (NDC 41167-1710). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine HCl 4%

Menthol 1 %

Purposes

Topical anesthetic

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 carton.
  • avoid contact with eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics  
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds

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, alcohol denat. (15%), 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, steareth-21, water

Keep Carton As It Contains Important Information

Close cap tightly between uses.

Principal Display Panel

ICY HOT
MAX
LIDOCAINE
PAIN RELIEF CREAM
Net Wt 2.7 OZ (76.5 g)

Icy Hotmaxlidocainepain Relief Creamnet Wt 2.7 Oz (76.5 G) (Icy Hot Cream 01)

Icy Hotmaxlidocainepain Relief Creamnet Wt 2.7 Oz (76.5 G) (Icy Hot Cream 01)

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