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
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
Label
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| 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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