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Aspercreme

Dosage form: patch
Ingredients: LIDOCAINE 246mg
Labeler: Lead Chemical Co. Ltd.
NDC Code: 62168-0584

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 Lidocaine Patch

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use
more than 1 patch on your body at a time 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
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
dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

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:

clean and dry affected area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water (333-030)

Package/Label Principal Display Panel

MAX STRENGTH LIDOCAINE

ODOR FREE
Aspercreme®
LIDOCAINE PATCH
THE NUMBER ONE ODOR FREE CREME BRAND

NUMBS
AWAY PAIN

Desensitizes
Aggravated Nerves
Fact Acting
Targets More
Pain Receptors*
Non Irritating

Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm) each

Pain Relieving Ointment on
a Breathable Adhesive Pad
4% Lidocaine

Label

ASPERCREME 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0584
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE246 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
GLYCERIN 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TARTARIC ACID 
TITANIUM DIOXIDE 
UREA 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0584-0810 POUCH in 1 CARTON
11 PATCH in 1 POUCH
2NDC:62168-0584-11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/16/2016
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.693727091ANALYSIS(62168-0584), MANUFACTURE(62168-0584)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.718216992MANUFACTURE(62168-0584)

 
Lead Chemical Co. Ltd.

Medically reviewed on Sep 18, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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