FDA.reportPublic FDA data

Numbing Cream

Manufacturer
BLOOMWELL GARDENS LLC
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:05:48

Label at a glance#

ProductNumbing Cream
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Temporarily helps reduce discomfort from: Minor burns,Insect bites,Minor 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,Minor 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 on large areas of the body or on broken, blistered, or abraded skin.

Avoid contact with eyes, mouth, and mucous membranes.

If pregnant or breastfeeding, consult a healthcare provider before use.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens or symptomspersist for more than 7 days.

Skin irritation, rash, or allergic reaction occurs.

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:

▪ 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

85284-003-0185284-003-01

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
85284-003-01Numbing 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
85284-00385284-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER0A5MM307FCIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALLANTOIN344S277G0ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
38715ce6-d073-dfe5-e063-6394a90a24f038715ce6-d072-dfe5-e063-6394a90a24f02025-06-25WarningsExact identifier
spl id: 38715ce6-d073-dfe5-e063-6394a90a24f0
spl set id: 38715ce6-d072-dfe5-e063-6394a90a24f0

Reported adverse events (FAERS/openFDA)#

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