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NDC 71662-0001-06 Re-Lieved Lidocaine Patch 4; 1 mg/100mg; mg/100mg Details

Re-Lieved Lidocaine Patch 4; 1 mg/100mg; mg/100mg

Re-Lieved Lidocaine Patch is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Transfer Technology. The primary component is LIDOCAINE; MENTHOL, (+)-.

Product Information

NDC	71662-0001
Product ID	71662-001_ba5cd48c-cd44-2f63-e053-2a95a90a930f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Re-Lieved Lidocaine Patch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Patch 4%
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	4; 1
Active Ingredient Units	mg/100mg; mg/100mg
Substance Name	LIDOCAINE; MENTHOL, (+)-
Labeler Name	Transfer Technology
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71662-0001-06 (71662000106)

Pricing Information	N/A
NDC Package Code	71662-001-06
Billing NDC	71662000106
Package	5 mg in 1 POUCH (71662-001-06)
Marketing Start Date	2021-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba5cd48c-cd43-2f63-e053-2a95a90a930f Details

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical Analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. The adhesoin properties of this patch may cause an extended period of redness. Please visit www.re-lieved.com for more information.

Do not use

If you are allergic to Lidocaine. On open wounds or on damaged, broken or irritated skin. Remove immidiately if you sense a burning sensation after application.

When using this product

Do not use other topical products
Do not allow contact with eyes or mucous membranes
Keep away from excessive heat. Do not apply heating pad to area of use
Apply only to clean, dry and untreated skin
Use only as directed. Read and follow all directions and warnings on this label

Ask your doctor or pharmacist before use if you are

using blood thinning medication, steroids, or non-steroidal anti-inflammatory druns (NSAIDs), or if you have sensitive skin.

Stop use or ask a doctor if

Condition worsens
Symptoms persist for more than 7 days

If pregnant or breast feeding

ask a physician before use.

Keep out of reach of children

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Directions adults/children 12 years or older

Clean and dry affected area
Peel patch off plastic liner and place on affected area for no more than 12 hours
Wash hands after applying patch.
Under age 12, consult a physician before use
For easier removal of the patc, apply rubbing alcohol or baby oil to adhesive edge while gently peeling

Other information

store at room termperature
Do not exceed 100 o Fahrenheit, 38 o Celsius

Inactive Ingredients

Acrylic adhesive, Polyethylene fabric

Re-Lieved Lidocaine-Menthol

INGREDIENTS AND APPEARANCE

RE-LIEVED LIDOCAINE PATCH

lidocaine patch 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71662-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	1 mg in 100 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71662-001-06	5 mg in 1 POUCH; Type 0: Not a Combination Product	02/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2021

Labeler - Transfer Technology (037968132)

Registrant - Transfer Technology (037968132)

Name	Address	ID/FEI	Business Operations
Establishment
Transfer Technoloy		037968132	manufacture(71662-001)

Revised: 1/2021

Document Id: ba5cd48c-cd44-2f63-e053-2a95a90a930f

Set id: ba5cd48c-cd43-2f63-e053-2a95a90a930f

Version: 1

Effective Time: 20210120