FDA.reportPublic FDA data

Doan's ® Pain Relieving Cream

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2016-06-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:57:51

Label at a glance#

ProductDoans Pain Relieving
Active ingredientLidocaine, menthol, unspecified form
Label structure9 sections

Dosage and administration

Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours do not exceed 3 applications in a 24 hour period Children 12 years and younger: ask a doctor

Storage and handling

Store at controlled room temperature 20-25 C (66-78 F). Child resistant packaging. Close cap tightly between uses.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Lidocaine 4% w/wTopical Anesthetic
Menthol 1%Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you have had an allergic reaction to lidocaine, or other local anesthetics
  • over a large area of the body, or on cut, irritated, punctured, blistered, or swollen skin
  • 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.
    Keep this carton for important information.
  • avoid contact with eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • wash hands after applying

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Store out of reach of children and pets.

Dispose of product out of the reach of children and pets. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours
  • do not exceed 3 applications in a 24 hour period

Children 12 years and younger: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20-25 C (66-78 F). Child resistant packaging. Close cap tightly between uses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, tocopheryl acetate

Questions or Comments

OTC - QUESTIONS SECTION

1-800-790-6417

PRINCIPAL DISPLAY PANEL - 77.9 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength Lidocaine

Available Without a Prescription

DOAN'S®
Pain Relieving Cream
with
4%
LIDOCAINE
PLUS
MENTHOL

DUAL ACTION
Local Anesthetic + Topical Analgesic

  • NUMBS AWAY PAIN
  • Non-Greasy
  • Fast Acting

NET WT.
2.75 oz (77.9g)

Principal Display Panel - 77.9 g Tube Carton
Principal Display Panel - 77.9 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1740883DOANS Pain Relieving 4 % / 1 % Topical CreamPSN3
250912lidocaine 4 % / menthol 1 % Topical CreamPSN3
1740883lidocaine 40 MG/ML / menthol 10 MG/ML Topical Cream [Doans Pain Relieving]SBD3
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD3
1740883Doans Pain Relieving 4 % / 1 % Topical CreamSY3
250912lidocaine 4 % / menthol 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55741-002-032020-01-31C16284748780-19d75b9d0-f076-f424-e053-dadaa90a57ceDoan's ® Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-002-03Doans Pain Relieving1 in 1 CARTONCREAM13
55741-002-03Doans Pain Relieving77.9 g in 1 TUBECREAM77.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-002DOANS PAIN RELIEVING (LIDOCAINE AND MENTHOL, UNSPECIFIED FORM) CREAM [DR. REDDY'S LABORATORIES INC.]3Legacy NDC, 2 package rows20181220_d90f59e8-7d6b-461b-9626-e568e40c23e2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55741-00255741-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
menthol, unspecified formL7T10EIP3AACTIB
benzyl alcoholLKG8494WBHIACT
carbomer homopolymer type B (Allyl Pentaerythritol crosslinked)HHT01ZNK31IACT
lecithin, soybean1DI56QDM62IACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
.alpha.-tocopherol acetate9E8X80D2L0IACT

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
49a8cb19-b55d-4695-73fe-49f1cd1ab4b3d90f59e8-7d6b-461b-9626-e568e40c23e22016-06-15WarningsExact identifier
spl id: 49a8cb19-b55d-4695-73fe-49f1cd1ab4b3
spl set id: d90f59e8-7d6b-461b-9626-e568e40c23e2

Reported adverse events (FAERS/openFDA)#

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