Uber Numb Topical Anesthetic Cream

Uber Numb Topical Anesthetic Cream
SPL v7
SPL
SPL Set ID 4939a547-c94b-3350-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-23

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 42229-5

Store at room temperature. Avoid direct sunlight

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,
  • Clean affected area with warm water and mild soap. Rinse thoroughly.
  • Gently dry by patting with toilet tissue or soft cloth.
  • Apply externally to area up to six times per day.

How to Apply:

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.

When Using This Product, 
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not insert this product into rectum using fingers or any mechanical device.
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 42229-5 (42229-5)

Store at room temperature. Avoid direct sunlight

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,
  • Clean affected area with warm water and mild soap. Rinse thoroughly.
  • Gently dry by patting with toilet tissue or soft cloth.
  • Apply externally to area up to six times per day.

How to Apply:

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.

When Using This Product,  (When using this product, )
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not insert this product into rectum using fingers or any mechanical device.
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

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