Aspercreme: Package Insert and Label Information

ASPERCREME- lidocaine patch
Lead Chemical Co. Ltd.

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.

Active ingredient – Lidocaine Patch US 1ct

Lidocaine 4%

Purpose – Lidocaine Patch US 1ct

Topical anesthetic

Use – Lidocaine Patch US 1ct

for the temporary relief of pain

Warnings – Lidocaine Patch US 1ct

For external use only

Do not use – Lidocaine Patch US 1ct

on puncture wounds, cuts, irritated or swollen skin
more than 1 patch on your body at a time or with other topical analgesics at the same time
with a heating pad or apply local heat to the area of use

When using this product – Lidocaine Patch US 1ct

use only as directed
do not bandage tightly
avoid contact with the eyes
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 – Lidocaine Patch US 1ct

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding, – Lidocaine Patch US 1ct

ask a health professional before use.

Keep out of reach of children and pets. – Lidocaine Patch US 1ct

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

Directions – Lidocaine Patch US 1ct

adults and children 12 years of age and older:

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 at a time and not more than 3 to 4 times daily

children under 12 years or age: consult a doctor

Inactive ingredients – Lidocaine Patch US 1ct

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

Active ingredient – Lidocaine Patch Singles US 1ct

Lidocaine 4%

Purpose – Lidocaine Patch Singles US 1ct

Topical Anesthetic

Use – Lidocaine Patch Singles US 1ct

temporarily relieves minor pain

Warnings – Lidocaine Patch Singles US 1ct

For external use only

Do not use – Lidocaine Patch Singles US 1ct

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 – Lidocaine Patch Singles US 1ct

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 – Lidocaine Patch Singles US 1ct

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, – Lidocaine Patch Singles US 1ct

ask a health professional before use.

Keep out of reach of children and pets. – Lidocaine Patch Singles US 1ct

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

Directions – Lidocaine Patch Singles US 1ct

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 – Lidocaine Patch Singles US 1ct

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

Package/Label Principal Display Panel – Lidocaine Patch US 1ct

MAX STRENGTH

Aspercreme®
with 4% LIDOCAINE
PAIN RELIEF PATCH

NUMBS AWAY PAIN
FAST ACTING
TARGETS NERVES
FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE
Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.


CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN
37409-0219 USA
©2020www.aspercreme.com Made in Japan

image-01
(click image for full-size original)

Label

Package/Label Principal Display Panel – Lidocaine Patch Singles US 1ct

MAX STRENGTH LIDOCAINE
NOW WITH
BETTER ADHESION*

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

NUMBS
AWAY PAIN

Powerful
Pain Relief
Fast Acting
Non Irritating

*Compared to previous formulation of the Aspercreme® with Lidocaine Patch.
Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
Pain Relieving Ointment on a Breathable Adhesive Pad
4% Lidocaine


SANOFI
Dist. by Chattem, Inc.,
a Sanofi Company
P.O. Box 2219
Chattanooga, TN
37409-0219 USA
©2020
www.aspercreme.comMade in Japan

image-02
(click image for full-size original)

Label

ASPERCREME lidocaine patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0584
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 246 mg
Inactive Ingredients
Ingredient Name Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
ALUMINUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
GLYCERIN
METHYLPARABEN
NONOXYNOL-30
POLYSORBATE 80
PROPYLENE GLYCOL
SILICON DIOXIDE
TARTARIC ACID
TITANIUM DIOXIDE
UREA
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62168-0584-1 1 PATCH in 1 POUCH None
2 NDC:62168-0584-2 400 POUCH in 1 CARTON contains a POUCH
2 1 PATCH in 1 POUCH This package is contained within the CARTON (62168-0584-2)
3 NDC:62168-0584-3 400 POUCH in 1 CARTON contains a POUCH
3 1 PATCH in 1 POUCH This package is contained within the CARTON (62168-0584-3)
4 NDC:62168-0584-4 400 POUCH in 1 CARTON contains a POUCH
4 1 PATCH in 1 POUCH This package is contained within the CARTON (62168-0584-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/16/2016
Labeler — Lead Chemical Co. Ltd. (693727091)
Registrant — Lead Chemical Co. Ltd. (693727091)
Establishment
Name Address ID/FEI Operations
Lead Chemical Co. Ltd. 718216992 ANALYSIS (62168-0584), MANUFACTURE (62168-0584)

Revised: 09/2021 Lead Chemical Co. Ltd.

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