Topicaine 5

Topicaine 5
SPL v10
SPL
SPL Set ID 15d33ff7-34ed-253d-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2003-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Glycerin Aloe Vera Leaf Benzyl Alcohol .alpha.-bisabolol, (+/-)- Shea Butter Edetate Disodium Polyacrylic Acid (8000 Mw) Glyceryl Laurate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-04-20

Description

Lidocaine 5% w/w

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 5% w/w

Uses

For the temporary relief of pain and itching due to anorectal disorders.

Warnings

For external use only

Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.

Directions
  • When practical, clean area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.
Active Ingredient

Lidocaine 5% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40, Shea Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

When Using This Product
  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not put in rectum
  • do not exceed recommended dosage unless directed by a doctor

Stop Use and Ask A Doctor If:
  • allergic reaction occurs
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Label On Tube and Outer Carton

Labeling printed on tube of Topicaine 5% 10 g

Outer carton of Topicaine 5% 10 g tube

Label affixed to tube of Topicaine 5 % 30 g tube

Outer carton of Topicaine 5 % 30 g tube:

Label affixed to tube to Topicaine 5% 113 g

Keep Out of the Reach of Children

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


Structured Label Content

Uses

For the temporary relief of pain and itching due to anorectal disorders.

Purpose

Topical Anesthetic

Warnings

For external use only

Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.

Directions
  • When practical, clean area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.
Active Ingredient

Lidocaine 5% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40, Shea Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not put in rectum
  • do not exceed recommended dosage unless directed by a doctor

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • allergic reaction occurs
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Label On Tube and Outer Carton (Label on tube and outer carton)

Labeling printed on tube of Topicaine 5% 10 g

Outer carton of Topicaine 5% 10 g tube

Label affixed to tube of Topicaine 5 % 30 g tube

Outer carton of Topicaine 5 % 30 g tube:

Label affixed to tube to Topicaine 5% 113 g

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

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


Advanced Ingredient Data


Raw Label Data

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