Aspercreme Lidocaine With Rosemary And Mint Cream
FDA Label NDC 41167-0565

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 Lidocaine With Rosemary And Mint (NDC 41167-0565). 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, use, 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 HCl 4%

Purpose

Topical anesthetic

Use

for the temporary relief of pain

Warnings

For external use only

Do Not Use

  • in large quantities
  • on wounds or on irritated or damaged skin
  • with a heating pad

When Using This Product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation occurs
  • you experience severe burning 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older:
    • apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily
    • massage until thoroughly absorbed into skin
    • wash hands thoroughly with soap and water after each use
    • children under 12 years of age: ask a doctor

Inactive Ingredients

water, cetearyl alcohol, alcohol denat., ceteth-20 phosphate, dimethicone, caprylyl methicone, dicetyl phosphate, C30-45 alkyl cetearyl dimethicone crosspolymer, triethyl citrate, glycerl stearate, potassium hydroxide, aloe barbadensis leaf juice, hydroxyacetophenone, fragrance, acrylates/C10-30 alkyl acrylate crossploymer, ethylhexylglycerin, panthenol, tocopheryl acetate, magnesium ascorbyl phosphate

Child-resistant packaging. Close cap tightly after use.

Principal Display Panel

NEW!
MAX STRENGTH
Aspercreme®
WITH 4% LIDOCAINE
PAIN RELIEF CREAM
NUMBS
AWAY PAIN
#1
LIDOCAIN
BRAND*
FAST ACTING
TARGETS NERVES
FRESH
ROSEMARY MINT
SCENT
With
ROSEMARY
& MINT
Essential Oils
*Among OTC topical analgesics.
NET WT 1.75 OZ (49.6 g)

Principal Display Panelnew!max Strengthaspercreme®with 4% Lidocainepain Relief Creamnumbsaway Pain#1lidocainbrand*fast Actingtargets Nervesfreshrosemary Mintscentwithrosemary& Mintessential Oils*among Otc Topical Analgesics.net Wt 1.75 Oz (49.6 G) (Aspercreme Lidocaine With Rosemary And Mint 01)

Principal Display Panelnew!max Strengthaspercreme®with 4% Lidocainepain Relief Creamnumbsaway Pain#1lidocainbrand*fast Actingtargets Nervesfreshrosemary Mintscentwithrosemary& Mintessential Oils*among Otc Topical Analgesics.net Wt 1.75 Oz (49.6 G) (Aspercreme Lidocaine With Rosemary And Mint 01)

* Please review the disclaimer below.