Aspercreme LIDOCAINE LEAD CHEMICAL CO. LTD. FDA Approved Use – Lidocaine Patch US 1ct for the temporary relief of pain Use – Lidocaine Patch Singles US 1ct For the temporarily relief of pain
FunFoxMeds box
Substance Lidocaine
Route
TOPICAL
Applications
505G(A)(3)

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient – Lidocaine Patch US 1ct Lidocaine 4% Active ingredient – Lidocaine Patch Singles US 1ct Lidocaine 4%
Inactive Ingredients
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 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
Strengths
4 %
Treats Conditions
Use Lidocaine Patch Us 1ct For The Temporary Relief Of Pain Use Lidocaine Patch Singles Us 1ct For The Temporarily Relief Of Pain

Identifiers & Packaging

Container Type BOX
UNII
98PI200987
Packaging

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. Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2022 www.aspercreme.com Made in Japan Label image-01; Package/Label Principal Display Panel – Lidocaine Patch Singles 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 ©2020 www.aspercreme.com Made in Japan Label image-02

Package Descriptions
  • 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. Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2022 www.aspercreme.com Made in Japan Label image-01
  • Package/Label Principal Display Panel – Lidocaine Patch Singles 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 ©2020 www.aspercreme.com Made in Japan Label image-02

Overview

Use – Lidocaine Patch US 1ct for the temporary relief of pain Use – Lidocaine Patch Singles US 1ct For the temporarily relief of pain

Indications & Usage

Use – Lidocaine Patch US 1ct for the temporary relief of pain Use – Lidocaine Patch Singles US 1ct For the temporarily relief of pain

Dosage & Administration

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 • apply to the affected area not more than 3 to 4 times daily • wash hands after applying or removing patch. Throw away the patch after folding sticky ends together. • children under 12 years of age: ask a doctor Directions – Lidocaine Patch Singles US 1ct adults and children over 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 of age: consult a doctor

Warnings & Precautions
Warnings – Lidocaine Patch US 1ct For external use only Do not use – Lidocaine Patch US 1ct • on wounds or on irritated or damage skin • more than 1 patch on your body at a time or with other topical analgesics at the same time • with a heating pad When using this product – Lidocaine Patch US 1ct • use only as directed • do not bandage tightly • avoid contact with the eyes and mucous membranes • do not expose the area to local heat or to direct sunlight 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 is present or excessive skin irritation occurs • you experience severe burning 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 Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. If swallowed, get medical help or contact a Poison Control Center right away. Warnings – Lidocaine Patch Singles US 1ct For external use only Do not use – Lidocaine Patch Singles 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 Singles 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 Singles 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 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.
Purpose

Purpose – Lidocaine Patch US 1ct Topical anesthetic Purpose – Lidocaine Patch Singles US 1ct Topical anesthetic

Do Not Use

Do not use – Lidocaine Patch US 1ct • on wounds or on irritated or damage skin • more than 1 patch on your body at a time or with other topical analgesics at the same time • with a heating pad Do not use – Lidocaine Patch Singles 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

When using this product – Lidocaine Patch US 1ct • use only as directed • do not bandage tightly • avoid contact with the eyes and mucous membranes • do not expose the area to local heat or to direct sunlight When using this product – Lidocaine Patch Singles 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 & Ask a Doctor

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 is present or excessive skin irritation occurs • you experience severe burning pain, swelling, or blistering where the product was applied Stop use and ask a doctor if – Lidocaine Patch Singles 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

Keep Out of Reach of Children

Keep out of reach of children and pets. – Lidocaine Patch US 1ct Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. If swallowed, get medical help or contact a Poison Control Center right away. 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.


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