Lipocaine 5

Lipocaine 5
SPL v6
SPL
SPL Set ID 849d6e28-a6b8-7f49-e053-2a91aa0a497d
Route
TOPICAL
Published
Effective Date 2019-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Allantoin Xanthan Gum Sucrose Distearate .beta.-sitosterol Caprylhydroxamic Acid Glyceryl Caprylate Glycerin Cetyl Palmitate Cetyl Alcohol Water Isostearyl Alcohol Lecithin, Sunflower Triethyl Citrate Sucrose Stearate .alpha.-tocopherol Acetate, Dl- Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-18

Description

Lidocaine 5%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 5%

Use

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

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com

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%

Other Information:
  • Store at room temperature 20-25oC (68-77oF).
  • Child-Resistant Cap: push down and turn to open
  • Available in 1 Oz (30 g) and 4 Oz (113 g) tubes
Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

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

Lipocaine 5 tube 113 grams label

Lipocaine 5 tube 30 grams label

Outer carton of Lipocaine 5 - 30 g tube

Keep Out of the Reach of Children:

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Use

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

Purpose

Topical Anesthetic

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com

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: (Active ingredient:)

Lidocaine 5%

Other Information: (Other information:)
  • Store at room temperature 20-25oC (68-77oF).
  • Child-Resistant Cap: push down and turn to open
  • Available in 1 Oz (30 g) and 4 Oz (113 g) tubes
Inactive Ingredients: (Inactive ingredients:)

Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

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)

Lipocaine 5 tube 113 grams label

Lipocaine 5 tube 30 grams label

Outer carton of Lipocaine 5 - 30 g tube

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 (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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