PEDIFIX LIDOCAINE PAIN-RELIEF PATCHES- lidocaine pain-relief patches patch

PediFix Lidocaine Pain-Relief Patches by

Drug Labeling and Warnings

PediFix Lidocaine Pain-Relief Patches by is a Otc medication manufactured, distributed, or labeled by PediFix, Inc, PediFix, AKRON. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

lIDOCAINE 4%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

Temporarily relieves minor pain

WARNINGS

For external use only

DO NOT USE

On cut, irritated, or swollen skin. On puncture wounds. For more than one week without
consulting a doctor. If you are allergic to any active or inactive ingredient. If the pouch is
damaged or opened.

WHEN USING

• Use only as directed.
• Read and follow all directions and warnings on this carton.
• Avoid contact with the eyes, mucous membranes, or rashes.
• 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 patches in a manner that always keeps the product away from children and pets. Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.
  

STOP USE

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.
• Conditions worsen.
• Symptoms persist for more than 7 days or clear up and occur again within a few days.
  

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over:

• Clean and dry the affected area.
• Carefully remove the backing from the patch starting at the corner.
• Apply the sticky side of the patch to the affected area.
• Use one patch for up to 8 hours.
• Discard the patch after a single use.

Children under 12 years of age: Consult a physician before use.

OTHER SAFETY INFORMATION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

INACTIVE INGREDIENT

Acrylic block co-polymer adhesive

SPL UNCLASSIFIED SECTION

Call 1-800-PEDIFIX (733-4349),
write to PediFix, 301 Fields Lane,
Brewster, NY 10509, or
visit pedifix.com.

PRINCIPAL DISPLAY PANEL

PediFix

Meidcal Footcare

Lidocain

Pain-Relief

Patches

Relieve Pain Instantly!

Scissor-Trim to Any Size

Water-Resistant

Unscented

4% Lidocaine Topical Anesthetic

Maximum Strength

6

Medicated Patches

Trim to Any Size

INGREDIENTS AND APPEARANCE

PEDIFIX LIDOCAINE PAIN-RELIEF PATCHES 
lidocaine pain-relief patches patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68927-3700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)	49.6 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68927-3700-1	2 in 1 CONTAINER	05/05/2025
1		3 in 1 CELLO PACK
1		4 mg 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 Drug	M017	05/05/2025

Labeler - PediFix, Inc (122271935)

Registrant - PediFix, Inc (122271935)

Establishment
Name	Address	ID/FEI	Business Operations
PediFix		122271935	pack(68927-3700)

Establishment
Name	Address	ID/FEI	Business Operations
AKRON		186569323	manufacture(68927-3700)