Topical Cream

Manufacturer
BLOOMWELL GARDENS LLC
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:13

Label at a glance#

ProductTopical Cream
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

Temporarily helps reduce discomfort from : Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming sensitivity,External itching or rash due to dry skin

Dosage and administration

▪ Adults and children over 12 years: ▪ Apply a thin layer to affected area not more than 3–4 times daily ▪ Children under 12 years: Consult a doctor before use ▪ Wash hands after application

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% ---Topical anesthetic

PURPOSE

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily helps reduce discomfort from :

Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming

sensitivity,External itching or rash due to dry skin

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

In or near eyes

▪ On large areas of the body or on broken, blistered, or abraded skin

▪ If allergic to local anesthetics such as lidocaine

When using this product:

▪ Avoid contact with eyes

▪ Do not bandage tightly or use with heating pad

▪ Keep out of reach of children

Stop use and ask a doctor if:

▪ Condition worsens or symptoms persist more than 7 days

Redness, rash, or irritation develops

▪ 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 not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E),

Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

Other information

OTHER SAFETY INFORMATION

Store at room temperature (15–30°C / 59–86°F)

Tamper evident: Do not use if seal is broken or missing

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85284-002-0185284-002-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % Topical CreamSY1

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
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
85284-002-01Topical Cream50 g in 1 BOTTLE, PLASTICCREAM501

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85284-00285284-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
37bd328e-83bb-781d-e063-6294a90ad8a437bd328e-83ba-781d-e063-6294a90ad8a42025-06-16WarningsExact identifier
spl id: 37bd328e-83bb-781d-e063-6294a90ad8a4
spl set id: 37bd328e-83ba-781d-e063-6294a90ad8a4

Reported adverse events (FAERS/openFDA)#

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