BlackBull Numbed As FXXK Cream 57 mL

Manufacturer
Blackbull Store LLC
Effective date
2023-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:51

Label at a glance#

ProductNumbed As FXXK
Active ingredientLIDOCAINE
Label structure11 sections

Dosage and administration

Adults and children 2 years old and older Clean the affected area Apply to affected area not more than 3 to 4 times daily Remove residue if desired Children under 2 years old: Consult a doctor

Storage and handling

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away +1 800-222-1222

OTC - STOP USE SECTION

Stop Use and Ask a Doctor if the condition worsens ■ symptoms persist for more than seven days or clear up and occur again within a few days. Rash or irritation develops, persists, or increases. If pregnant or breastfeeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years old and older Clean the affected area Apply to affected area not more than 3 to 4 times daily Remove residue if desired Children under 2 years old: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclopentasiloxane, Denatonium Benzoate,Dicetyl Phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Gyceryl Stearate, lsohexadecane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Maltodextrin, Phenoxyethanol, Simmondsia Chinensis(Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Water.

OTC - QUESTIONS SECTION

Call (754) 248 - 2548

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 57mLLabel 57mL2 OZ Cream, NDC: 83371-112-11

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83371-112-112025-01-30C16284748780-12cef2736-aa93-d83d-e063-dadaa90ab31fBlackBull Numbed As FXXK Cream 57 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83371-112-11Numbed As FXXK57 mL in 1 TUBECREAM571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83371-112NUMBED AS FXXK (TOPICAL ANESTHETIC CREAM) CREAM [BLACKBULL STORE LLC]11 package rows20230810_0011c61b-e3cd-d909-e063-6394a90a6ac2.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83371-11283371-112-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
0011c61b-e3ce-d909-e063-6394a90a6ac20011c61b-e3cd-d909-e063-6394a90a6ac22023-07-09WarningsExact identifier
spl id: 0011c61b-e3ce-d909-e063-6394a90a6ac2
spl set id: 0011c61b-e3cd-d909-e063-6394a90a6ac2

Reported adverse events (FAERS/openFDA)#

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