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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
May 12, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Lidocaine(50 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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Product Details

NDC Product Code
63742-032
Application Number
M015
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 12, 2025
ALLANTOINInactive
Code: 344S277G0ZClass: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FCClass: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7JClass: IACT
DIMETHYL ISOSORBIDEInactive
Code: SA6A6V432SClass: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MMClass: IACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEInactive
Code: VLW429K27KClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0CClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
LidocaineActive
Code: 98PI200987Class: ACTIBQuantity: 50 mg in 1 g

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling 119:

119


INDICATIONS & USAGE SECTION

Uses:

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

WARNINGS SECTION

Warnings

(For external use only)

Do not use

this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • tamper evident "Do not use this product" if seal is broken or missing.

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using finger or any medical device or applicator.

Stop use and ask a doctor if

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep out of reach of children

In case of accidental ingestion, seek medical attention immediately.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic


SPL UNCLASSIFIED SECTION

Other Information

  • keep away from direct sunlight or heat.
  • store in room temperature (59-86°F/15-30°C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine


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