Simply Vital Hemorrhoid & Anorectal Relief

Simply Vital Hemorrhoid & Anorectal Relief
SPL v2
SPL
SPL Set ID 79fa4b89-382f-45fa-a792-90a9fe5bf573
Route
TOPICAL
Published
Effective Date 2021-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Allantoin Water Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Propylene Glycol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-09

Description

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)


Medication Information

Purpose

Anorectal (hemorrhoidal)

Description

Lidocaine 5.00 %

Uses:
  • For the temporary relief of itching and discomfort in the perianal area.
  • For the temporary relief of pain, soreness, or burning.
Do Not
  • Put this product into the rectum by using fingers or any mechanical device or applicator.
  • Exceed the recommended daily dosage unless directed by a doctor.
Warnings:

For external use only.

Questions?

+1 (205) 624-9177

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.

• Children under 12 years of age: consult a doctor.

• Apply to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 5.00 %

Package Labeling:

Other Information:
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients:

Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).

When Using This Product
  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Discontinue Use and Consult A Doctor If
  • The symptoms being treated does not subside.
  • Redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persions can develop allergic reactions to ingredients in this product.

Allergy alert


Structured Label Content

Uses:
  • For the temporary relief of itching and discomfort in the perianal area.
  • For the temporary relief of pain, soreness, or burning.
Do Not (Do not)
  • Put this product into the rectum by using fingers or any mechanical device or applicator.
  • Exceed the recommended daily dosage unless directed by a doctor.
Purpose

Anorectal (hemorrhoidal)

Warnings:

For external use only.

Questions?

+1 (205) 624-9177

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.

• Children under 12 years of age: consult a doctor.

• Apply to the affected area up to 6 times daily.

Active Ingredient (Active ingredient)

Lidocaine 5.00 %

Package Labeling:

Other Information: (Other information:)
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients: (Inactive ingredients:)

Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).

When Using This Product (When using this product)
  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Discontinue Use and Consult A Doctor If (Discontinue use and consult a doctor if)
  • The symptoms being treated does not subside.
  • Redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persions can develop allergic reactions to ingredients in this product.

Allergy alert


Advanced Ingredient Data


Raw Label Data

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