ASPERFLEX 24HRS- lidocaine patch 4% patch

ASPERFLEX 24HRS by

Drug Labeling and Warnings

ASPERFLEX 24HRS by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc., SLV Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Idications and Usage

Uses: Temporaily relieves minor pains.

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

• 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.

Do not Use

• 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.

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

NDC: 71399-3884-6

Package size: 6 Patches

Questions?

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A

Re-Lieved Lidocaine 4% Patch

INGREDIENTS AND APPEARANCE

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)