Uber Numb Topical Anesthetic Cream

Uber Numb Topical Anesthetic Cream
SPL v7
SPL
SPL Set ID 441c802f-a363-1530-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Allantoin Water Benzyl Alcohol Carboxypolymethylene Propylene Glycol .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-20

Description

Lidocaine HCl 5.00%


Medication Information

Description

Lidocaine HCl 5.00%

Uses:

For the temporary relief of local pain and discomfort associated with anorectal disorders.

Section 55105-1

Local Anesthetic

Warnings:
  • For external use only. Use only as directed. 
Directions:
  • apply to affected area. Adults and children 12-years and over:
  • consult a physician before use. Children under 12,
  • How to Apply:
  • Clean affected area with warm water nad mild soap. Rinse thoroughly.
  • Gently dry by patting with toilet tissue or soft cloth.
  • Apply externally to area up to six times per day.
Do Not Insert 

this product into rectum using fingers or any mechanical device.

Package Labeling:

Active Ingredient:

Lidocaine HCl 5.00%

Other Ingredients:

Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • Store at room temperature. Avoid direct sunlight
When Using This Product,

do not exceed the recommended daily dosage unless directed by a doctor.

Stop Using This Product If:
  • Symptoms worsen or does not improve within seven days
  • Bleeding occurs. Redness, irritation, swelling, pain or other symptoms develop.
Keep Out of Reach of Children.

Children under 12 should consult physician prior to use.


Structured Label Content

Uses:

For the temporary relief of local pain and discomfort associated with anorectal disorders.

Section 55105-1 (55105-1)

Local Anesthetic

Warnings:
  • For external use only. Use only as directed. 
Directions:
  • apply to affected area. Adults and children 12-years and over:
  • consult a physician before use. Children under 12,
  • How to Apply:
  • Clean affected area with warm water nad mild soap. Rinse thoroughly.
  • Gently dry by patting with toilet tissue or soft cloth.
  • Apply externally to area up to six times per day.
Do Not Insert  (Do not insert )

this product into rectum using fingers or any mechanical device.

Package Labeling:

Active Ingredient:

Lidocaine HCl 5.00%

Other Ingredients:

Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • Store at room temperature. Avoid direct sunlight
When Using This Product, (When using this product,)

do not exceed the recommended daily dosage unless directed by a doctor.

Stop Using This Product If: (Stop using this product if:)
  • Symptoms worsen or does not improve within seven days
  • Bleeding occurs. Redness, irritation, swelling, pain or other symptoms develop.
Keep Out of Reach of Children. (Keep out of reach of children.)

Children under 12 should consult physician prior to use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)