Aspercreme With Lidocaine Pain Relieving Creme Lotion
FDA Label NDC 41167-0582

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 Aspercreme With Lidocaine Pain Relieving Creme (NDC 41167-0582). 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 ingredient, purpose, 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 Ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

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.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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

    • children 12 years and 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, methylparaben, SD alcohol 40 (15%), steareth-21, water (309-124)

Principal Display Panel

ODOR FREE
Aspercreme
WITH 4% LIDOCAINE
MAXIMUM STRENGTH
Pain Relieving Crème
Net wt 2.7 oz (76.5 g)

Odor Freeaspercremewith 4% Lidocainemaximum Strengthpain Relieving Crèmenet Wt 2.7 Oz (76.5 G) (Aspercreme With Lidocaine Pain Relieving Creme 01)

Odor Freeaspercremewith 4% Lidocainemaximum Strengthpain Relieving Crèmenet Wt 2.7 Oz (76.5 G) (Aspercreme With Lidocaine Pain Relieving Creme 01)

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