Aspercreme with Lidocaine Dry: Package Insert and Label Information

ASPERCREME WITH LIDOCAINE DRY- lidocaine spray
Chattem, Inc.

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.

ASPERCREME with LIDOCAINE SPRAY

Drug Facts

Active i ngredient

Purpose

Lidocaine 4%………………………………………………………………………………………………………………….Topical anesthetic

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

a dults 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

In active ingredients :

alcohol denat. (30%), caprylic/capric triglyceride, isobutane, propylene glycol

PRINCIPAL DISPLAY PANEL

MAX STRENGTH
Aspercreme
LIDOCAINE
PAIN RELIEF SPRAY
NET WT 4 OZ (113 g)

MAX STRENGTH
Aspercreme 
LIDOCAINE
PAIN RELIEF SPRAY
NET WT 4 OZ (113 g)
(click image for full-size original)
ASPERCREME WITH LIDOCAINE DRY
lidocaine spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0583
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
ISOBUTANE
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0583-5 113 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/02/2019
Labeler — Chattem, Inc. (003336013)

Revised: 06/2021 Chattem, Inc.

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