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SPL v4
SPL
SPL Set ID e75eb3e0-853b-4b85-8c31-86cbf58effaa
Route
TOPICAL
Published
Effective Date 2016-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Water Trolamine Carboxypolymethylene Propylene Glycol Benzyl Alcohol Diethylene Glycol Monoethyl Ether Neopentyl Glycol Dicaprylate/dicaprate Trideceth-10 Cholesterol Allantoin .alpha.-tocopherol Acetate Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-18

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses:

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

Warnings

(For external use only)

Directions
  • Adults: When practical, cleanse the affected area with mild soap and warm water and rise 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 under 12 years of age: consult a doctor.
Do Not Use

this product if

Active Ingredient

Lidocaine 5%

Other Information
  • Keep away from direct sunlight or heat.
  • Store in room temperature (59-86°F / 15-30°C).
Package Labeling:

Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

When Using This Product
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.
Pregnant Or Breast Feeding,
  • ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
  • Tamper Evident "Warranty Void...Seal..."label atop the container is broken.
Stop Use and Ask A Doctor If

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out of Reach of Children

In case of accidental ingestion, seek medical attention immediately.


Structured Label Content

Uses:

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

Purpose

Local Anesthetic

Warnings

(For external use only)

Directions
  • Adults: When practical, cleanse the affected area with mild soap and warm water and rise 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 under 12 years of age: consult a doctor.
Do Not Use (Do not use)

this product if

Active Ingredient

Lidocaine 5%

Other Information
  • Keep away from direct sunlight or heat.
  • Store in room temperature (59-86°F / 15-30°C).
Package Labeling:

Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

When Using This Product (When using this product)
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.
Pregnant Or Breast Feeding, (Pregnant or breast-feeding,)
  • ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
  • Tamper Evident "Warranty Void...Seal..."label atop the container is broken.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

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

In case of accidental ingestion, seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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