FDA.reportPublic FDA data

Dr. Scholls Blister Pain Relief Complete

Manufacturer
Scholl's Wellness Company LLC | Shanghai Sibei Cosmetic Co., Ltd.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:20

Label at a glance#

ProductDr. Scholls Blister Pain Relief Complete
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children over 12 years: Step 1 (Lidocaine patch application)  • apply to the affected area not more than 3-4 times daily clean and dry affected area remove backing from lidocaine patch by firmly grasping both ends and gently pulling away backing once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area once applied, press firmly on patch t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain

Warnings

WARNINGS SECTION

For external use only

  • Avoid contact with eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use

OTC - DO NOT USE SECTION

  • More than one patch on your body at a time
  • If you have had an allergic reaction to lidocaine or other local anesthetics
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • For more than one week without consulting a doctor.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed. Read and follow all directions and warnings on this carton

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • severe burning sensation, redness, rash or 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 breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

Step 1 (Lidocaine patch application) • apply to the affected area not more than 3-4 times daily

  • clean and dry affected area
  • remove backing from lidocaine patch by firmly grasping both ends and gently pulling away backing
  • once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
  • once applied, press firmly on patch to help adhesive adhere to blister
  • do not remove patch and reapply
  • once patch is applied, move to Step 2.

Step 2 (Bandage application) •remove backing film from hydrogel bandage marked "Step 1" and place center (adhesive side down) over skin to seal lidocaine patch and blister.

  • remove backing film marked "Step 2" and firmly smooth down adhesive edge to skin to seal lidocaine patch and blister. Replace when bandage begins to loosen

children 12 years or younger: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Silica Silylate, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tocopherol Acetate, Vanillyl Butyl Ether, Urea, Water (Aqua)

Questions?

OTC - QUESTIONS SECTION

1-866-360-3226

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelboxbox

Inner labelInner label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73469-0487-8Dr. Scholls Blister Pain Relief Complete1 in 1 KITKIT12
75568-024-01Dr. Scholls Blister Pain Relief Complete0.37 g in 1 PATCHPATCH2.96 g40 mg in 1g2
75568-024-01Dr. Scholls Blister Pain Relief Complete1 in 1 POUCHPATCH40 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73469-0487DR. SCHOLLS BLISTER PAIN RELIEF COMPLETE (LIDOCAINE) KIT [SCHOLL'S WELLNESS COMPANY LLC]2Current NDC, 3 package rows20250216_26e3a678-b28f-588b-e063-6394a90ac025.zip
75568-024DR. SCHOLLS BLISTER PAIN RELIEF COMPLETE (LIDOCAINE) KIT [SCHOLL'S WELLNESS COMPANY LLC]2Unmatched20250216_26e3a678-b28f-588b-e063-6394a90ac025.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75568-02475568-024-01
73469-048773469-0487-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE GUMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
LAUROCAPRAM1F3X9DRV9XIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Scholls Blister Pain Relief CompleteLIDOCAINEScholl's Wellness Company LLC26e3a678-b28f-588b-e063-6394a90ac0252024-12-18WarningsExact identifier
ndc (package): 75568-024-01
ndc (package): 73469-0487-8
ndc (product): 73469-0487
ndc11 (package): 75568002401
ndc11 (package): 73469048708
spl id: 29880f16-792e-934d-e063-6294a90a5f34
spl set id: 26e3a678-b28f-588b-e063-6394a90ac025
Dr. Scholls Blister Pain Relief CompleteLIDOCAINEScholl's Wellness Company LLCd860b339-48a0-405c-a67d-f7e7a31f63512024-12-18WarningsExact identifier
ndc (package): 75568-024-01
ndc11 (package): 75568002401

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.