Purpose
Lidocaine 4%..................................................................................................................................Topical anesthetic
Aspercreme With Lidocaine Dry Spray
FDA Label NDC 41167-0583
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 Dry (NDC 41167-0583). 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 purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
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.
■ do not allow contact with the eyes and mucous membranes
■ avoid spraying on face
■ avoid inhalation of spray
■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■ do not use at the same time as other topical analgesics
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
Extremely Flammable
■ do not use near heat or flame or while smoking
■ avoid long term storage above 104°F (40°C)
■ do not puncture or incinerate. Contents under pressure.
■ do not store at temperatures above 120°F (49°C)
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:
■ spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
■ product will dry quickly on its own, and does not need to be rubbed in
children 12 years or younger: ask a doctor
Inactive Ingredients:
caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40 (30%)
Principal Display Panel
MAX STRENGTH
ODOR FREE
ASPERCREME
with 4% LIDOCAINE
DRY SPRAY
NET WT 4 OZ (113 g)
Principal Display Panelmax Strengthodor Freeaspercreme With 4% Lidocainedry Spraynet Wt 4 Oz (113 G) (Aspercreme With Lidocaine Dry Spray 01)
* Please review the disclaimer below.
