AsperFlex™ MAX Pain Relief Lidocaine Patch

AsperFlex™ MAX Pain Relief Lidocaine Patch

Asperflex MAX is used for the temporary relief of minor aches and pains, including backaches, sore shoulders, stiff necks and joint pain. Made of comfortable fabric, Asperflex MAX provides the fastest, most targeted relief without a prescription.

Category:

Description

NDC: 71399-4453-05

ASPERFLEX MAX Pain Relief Lidocaine Patch

Active Ingredients:  Lidocaine 4%, Menthol 1%

Topical Anesthetic

Purpose:

Temporarily relieves minor pain.

Dosage and Administration Directions:

Adults and children over 12 years:

  • Clean and dry affected area.
  • Carefully remove backing from patch.
  • Starting at corner, apply sticky side of patch to affected area.
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • Use one patch at a time and not more than 3 to 4 daily.
  • Discard patch after single use.

 

Children under 12 years of age: consult a physician.

 

Warnings:

For external use only.

Indications and Usage:

  • Temporarily relieves minor pain.

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 use at the same time as other topical analgesics.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not microwave.
  • 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 consult 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 800-222- 1222

Other Safety Information:

store at room temperature 15°-30°C (59°-86°F).

Inactive Ingredients: aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide urea, poval, alcohol, water.

 

ASPERFLEX MAX lidocaine 4% with menthol 1% patch
PRODUCT INFORMATION
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-4453
Route of Administration TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE – UNII:98PI200987) LIDOCAINE 240 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL – UNII:L7T10EIP3A) MENTHOL 60 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ACRYLATE (UNII: WC487PR91H)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71399-4453-5 5 in 1 CARTON 11/04/2021
1 1 in 1 PATCH; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/04/2021
LABELER – AKRON PHARMA INC. (067878881)

 

Questions? Please Call 1(877) 225-6999

Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in the United States.