Numb Cream

Numb Cream
SPL v5
SPL
SPL Set ID a3ae5f00-01f4-4a8d-8dbf-cb1f930a8146
Route
TOPICAL
Published
Effective Date 2023-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Propylene Glycol Hydrogenated Soybean Lecithin Trolamine Isopropyl Myristate Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Polysorbate 80 .alpha.-tocopherol Acetate Cholesterol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Lidocaine 5% W/W


Medication Information

Warnings and Precautions

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 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 doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using ‑nger or any medical device or applicator.

Stop use and ask doctor if

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

Indications and Usage

For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

Dosage and Administration
  • 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 un 12 years of age consult a doctor.
Description

Lidocaine 5% W/W

Section 42229-5

• Keep away from direct sunlight or heat.

• Store at room temperature 15° to 30°C (59° to 86°F)

Section 50565-1

In case of accidental ingestion, sook modical attention immediately.

Section 51727-6

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purfied Water, Trolamine, Vitamin E Acetate

Section 51945-4

NUMB CREAM

NDC 82429-203-01

Lidocaine Cream 5%

NET WT 1.35 OZ (38g)

Section 55105-1

Local Anesthetic

Section 55106-9

Lidocaine 5% W/W


Structured Label Content

Indications and Usage (34067-9)

For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

Dosage and Administration (34068-7)
  • 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 un 12 years of age consult a doctor.
Warnings and Precautions (34071-1)

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 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 doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using ‑nger or any medical device or applicator.

Stop use and ask doctor if

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

Section 42229-5 (42229-5)

• Keep away from direct sunlight or heat.

• Store at room temperature 15° to 30°C (59° to 86°F)

Section 50565-1 (50565-1)

In case of accidental ingestion, sook modical attention immediately.

Section 51727-6 (51727-6)

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purfied Water, Trolamine, Vitamin E Acetate

Section 51945-4 (51945-4)

NUMB CREAM

NDC 82429-203-01

Lidocaine Cream 5%

NET WT 1.35 OZ (38g)

Section 55105-1 (55105-1)

Local Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5% W/W


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)