FDA.reportPublic FDA data

Numbing Cream

Manufacturer
100 KARMA INC
Effective date
2025-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:42

Label at a glance#

ProductNumbing Cream
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

4% lidocaine

OTC - PURPOSE SECTION

topical analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching!associated with minor skin irritations, minor burnssunburn,minor cuts,scrapes, insect bites.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this product if

  • Pregnant or breastfeeding, ask a health professional before use.
  • If there is any allergic reaction to this product.
  • In case of accidental overdose, get medical help, or contact the poison control center immediately.

OTC - WHEN USING SECTION

  • Only take the recommended daily dosage unless otherwise instructed by a doctor.
  • Some individuals may experience allergic reactions to the ingredients contained in this product.

OTC - STOP USE SECTION

Stop using and ask a doctor

  • If discomfort persists for 7 days.
  • The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children Avoid contact with eyes.
In case of accidental ingestion, seek medical attention immediately.

DOSAGE & ADMINISTRATION SECTION

  • For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
  • Apply up to 4 times a day.
  • For children under 12 years of age: Consult a doctor.

OTHER SAFETY INFORMATION

Store at 59°-86°F (15°-30°C). Avoid direct sunlight.

INACTIVE INGREDIENT SECTION

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Numbing CreamNumbing Cream

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85569-002-01Numbing Cream50 mL in 1 CARTONCREAM501

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
85569-00285569-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EMU OIL344821WD61IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 934Z135WT9208IACT

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
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
ndc (package): 85569-002-01
ndc (product): 85569-002
ndc11 (package): 85569000201
spl id: 359884d6-188b-e503-e063-6294a90acab4
spl set id: 359884d6-188a-e503-e063-6294a90acab4

Reported adverse events (FAERS/openFDA)#

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