AsperFlex™ Maximum Strength Lidocaine 24 Hour Patch

AsperFlex™ Maximum Strength Lidocaine 24 Hour Patch

Asperflex is used for the temporary relief of minor aches and pains, including backaches, sore shoulders, stiff necks and joint pain. Each patch contains three poweful pain fighters, including Camphor, Menthol and Methyl Salicylate. Each patch contains 4% Lidocaine.

Category:

Description

NDC: 71399-3884-06

ASPERFLEX 24 Hour Lidocaine Patch

Package contains 6 patches.

Active Ingredient:  Lidocaine 4%

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.
  • Use one patch for up to 24 hours.
  • 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.
  • 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.
  • 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 breastfeeding, 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 in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients Alicyclic Hydrocarbon Resin, Mineral Oil, Polyester film, Silicone –coated polyester film and styrene isoprene styrene block copolymer.

ASPERFLEX 24HRS lidocaine patch 4% patch
PRODUCT INFORMATION
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-3884
Route of Administration TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE – UNII:98PI200987) LIDOCAINE 40 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
MINERAL OIL (UNII: T5L8T28FGP)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71399-3884-6 6 in 1 CARTON 05/18/2021
1 1 in 1 POUCH
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 05/18/2021
LABELER – AKRON PHARMA INC. (067878881)
ESTABLISHMENT
Name Address ID/FEI Business Operations
SLV Pharmaceuticals LLC 081225162 manufacture(71399-3884)

Package size: 6 Patches

Questions? Please Call 1(877) 225-6999

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