DailyMed - ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

Contains inactivated NDC Code(s)
NDC Code(s): 71399-4453-5
Packager: Akron Pharma Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 12, 2023

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Drug Facts

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Active Ingredient
Lidocaine 4% Menthol 1%

Lidocaine 4%

Menthol 1%
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Purpose
Topical anesthetic

Topical anesthetic
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Uses
for the temporary relief of pain

for the temporary relief of pain
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Warnings
For external use only - Do not use - 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 ...
For external use only
Do not use
- 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
- use only as directed. Read and follow all directions and warnings on this carton.
- 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 and 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 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,

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 (1-800-222-1222).

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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 ...
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 at a time and not more than 3 to 4 times daily
children 12 years or younger: consult a doctor
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Other Information
store at room temperature 15°-30°C (59°-86°F).

store at room temperature 15°-30°C (59°-86°F).
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Inactive ingredients
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide urea, poval, alcohol, water

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide urea, poval, alcohol, water
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Questions or Comments?
Call toll-free 1-877-255-6999. Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 - www.akronpharma.com

Call toll-free 1-877-255-6999.

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com
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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
Feb 20, 2023	2 (current)	download
Nov 29, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1249758	lidocaine 4 % / menthol 1 % Medicated Patch	PSN
2	1249758	lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch	SCD
3	1249758	lidocaine 4 % / menthol 1 % Medicated Patch	SY

Label: ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children and pets.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children and pets.

Find additional resources

Safety

Related Resources

More Info on this Drug

ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

Number of versions: 2

ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

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ASPERFLEX MAX- lidocaine 4% with menthol 1% patch

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.