Dr Sabharwals

Manufacturer
Dr. Sabharwal's Wound Care | Dr Sabharwals Wound Care
Effective date
2023-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:35

Label at a glance#

ProductDr Sabharwals
Active ingredientLIDOCAINE
Label structure15 sections

Storage and handling

Store at room temperature 20-25 0 C (68-77 0 F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

OTC - PURPOSE SECTION

Topical anesthetic

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • More than one patch on your body at a time
  • On cut, irritated swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics

OTC - WHEN USING SECTION

  • Use only as directed.
  • Read and follow all directions and warnings on this label.
  • Rare case of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not use at the same time as other topical analgesic.
  • 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.
  • A transient burning sensation may occur uopn application but generally disappears in several days.
  • If a severe burning sensation occurs, discontinue use immediately.
  • Discontinue use at least 1 hour before a bath or shower.
  • Do not use immediately after a bath or shower.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INSTRUCTIONS FOR USE SECTION

Adult and children over 12 years

  • Clean and dry affected area.
  • Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
  • Use 1 patch for up to 12 hours.

Children 12 years or younger:

  • ask a doctor

STORAGE AND HANDLING SECTION

Store at room temperature 20-25 0C (68-77 0F)

INACTIVE INGREDIENT SECTION

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon
Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

OTC - QUESTIONS SECTION

Call +91-905-677-0088

DOSAGE & ADMINISTRATION SECTION

Topical Patch for External Use Only

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71318-111-152025-01-30C16284748780-12cef2736-5c53-d83d-e063-dadaa90ab31ff765a716-5e52-3daf-e053-6394a90acef0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71318-111-15Dr Sabharwals1 in 1 POUCHPATCH12
71318-111-15Dr Sabharwals15 in 1 CARTONPATCH152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71318-111DR SABHARWALS (LIDOCAINE GEL PATCH) PATCH [DR. SABHARWAL'S WOUND CARE]22 package rows20230328_f765a716-5e52-3daf-e053-6394a90acef0.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
71318-11171318-111-15

Ingredients#

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

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f7da7dbc-2968-a604-e053-6394a90a0443f765a716-5e52-3daf-e053-6394a90acef02023-03-26WarningsExact identifier
spl id: f7da7dbc-2968-a604-e053-6394a90a0443
spl set id: f765a716-5e52-3daf-e053-6394a90acef0

Reported adverse events (FAERS/openFDA)#

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