FDA.reportPublic FDA data

Numbing Pain Relief

Manufacturer
Walgreen Company
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:30

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Active ingredient Lidocaine 4%

OTC - PURPOSE SECTION

Purpose Topical analgesic

Uses

Uses

Temporarily relieves pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Directions And Dosage

Directions

Adults and children 2 years of age and older Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age do not use, consult a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Inner Fillet Leaf Juice, Avocado Fruit Oil, Carbomer, Emulsifying Wax, Glycerin, Jojoba Seed Oil, Lecithin, Phenoxyethanol, Shea Butter, Sodium Bicarbonate, Stearic Acid, Sweet Almond Oil, Tetrasodium Glutamate Diacetate, Vitamin E, Xanthan Gum

OTC - QUESTIONS SECTION

1-800-925-4733

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Numbing Pain Relief + Skin Moisturizing Cream LIDOCAINE 4% / TOPICAL ANALGESIC + Aloe & Vitamin E Provides temporary relief of pain Soothing relief that moisturizes & comforts Maximum strength lidocaine available without a prescription Free from Parabens, Fragrance NET WT 3 OZ (85 g)

Label Images#

6261-1AB-IFC R53407
6261-1AB-IFC R53407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
0363-6261-07Numbing Pain Relief1 in 1 CARTONCREAM12
0363-6261-07Numbing Pain Relief85 g in 1 APPLICATORCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6261NUMBING PAIN RELIEF (LIDOCAINE 4%) CREAM [WALGREEN COMPANY]2Current NDC, 2 package rows20250406_2425badb-e196-e9f8-e063-6294a90a7bf4.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-62610363-6261-07

Ingredients#

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
ALMOND OIL66YXD4DKO9IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
POLYSORBATE 60CAL22UVI4MIACT
CARBOMER 9404Q93RCW27EIACT
AVOCADOSDS87L369FIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
XANTHAN GUMTTV12P4NEEIACT
LIDOCAINE98PI200987ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT

Complete SPL Sections#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Lidocaine 4%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

WARNINGS SECTION

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age do not use, consult a doctor

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Inner Fillet Leaf Juice, Avocado Fruit Oil, Carbomer, Emulsifying Wax, Glycerin, Jojoba Seed Oil, Lecithin, Phenoxyethanol, Shea Butter, Sodium Bicarbonate, Stearic Acid, Sweet Almond Oil, Tetrasodium Glutamate Diacetate, Vitamin E, Xanthan Gum

Other information

OTHER SAFETY INFORMATION

store between 15° -30°C (59° -86°F)

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

1-800-925-4733

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015 Walgreens 100% SATISFACTION GUARANTEED walgreens.com ©2024 Walgreen Co. NDC 0363-6261-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Numbing Pain Relief + Skin Moisturizing Cream LIDOCAINE 4% / TOPICAL ANALGESIC + Aloe & Vitamin E Provides temporary relief of pain Soothing relief that moisturizes & comforts Maximum strength lidocaine available without a prescription Free from Parabens, Fragrance NET WT 3 OZ (85 g)

Source Document#

Source XML