Numb Plus Maximum Strength Anorectal Cream

Numb Plus Maximum Strength Anorectal Cream
SPL v4
SPL
SPL Set ID a7c37b2a-b647-43d7-b43b-87bbece35430
Route
TOPICAL
Published
Effective Date 2020-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Dimethyl Isosorbide Dodecane Ethylhexylglycerin Phenoxyethanol Propylene Glycol Edetate Sodium .alpha.-tocopherol Trolamine Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-09

Description

Lidocaine 5.00%

Purpose

Anorectal (Hermorrhoidal)


Medication Information

Purpose

Anorectal (Hermorrhoidal)

Description

Lidocaine 5.00%

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders 

Warnings

For external use only

Directions
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product
  • when first opening the jar, twist the cap and peel off the foil seal
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor 
Active Ingredient

Lidocaine 5.00%

Other Information
  • always keep the jar tightly closed
  • protect from freezing
  • store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)
Package Labeling:

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol

Questions Or Comments?

Call weekdays 9AM to 6PM PST at 1-844-700-6862 or email us at [email protected]

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

If Pregnant Or Breastfeeding, 

ask a health professional before use   

Stop the Use and Consult Doctor If
  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsens or does not improve within 7 days

Structured Label Content

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders 

Purpose

Anorectal (Hermorrhoidal)

Warnings

For external use only

Directions
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product
  • when first opening the jar, twist the cap and peel off the foil seal
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor 
Active Ingredient

Lidocaine 5.00%

Other Information
  • always keep the jar tightly closed
  • protect from freezing
  • store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)
Package Labeling:

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol

Questions Or Comments? (Questions or comments?)

Call weekdays 9AM to 6PM PST at 1-844-700-6862 or email us at [email protected]

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away

If Pregnant Or Breastfeeding,  (If pregnant or breastfeeding, )

ask a health professional before use   

Stop the Use and Consult Doctor If (Stop the use and consult doctor if)
  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsens or does not improve within 7 days

Advanced Ingredient Data


Raw Label Data

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