Anecream 5%

Anecream 5%
SPL v14
SPL
SPL Set ID 1810edc3-093e-402f-bcb0-9c731da283a7
Route
TOPICAL
Published
Effective Date 2016-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C Cholesterol Lecithin, Soybean Polysorbate 80 Propylene Glycol .alpha.-tocopherol Acetate, Dl- Trolamine Water Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-20

Description

Lidocaine 5% w/w

Purpose

Local anesthetic


Medication Information

Purpose



Local anesthetic

Description

Lidocaine 5% w/w

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings



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

Other Information

Store at USP controlled room temperature 20-25C (66-77F).

Active Ingredient:

Lidocaine 5% w/w

Inactive Ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.



When Using This Product
  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days
Anecream5 15g Tube Carton

AC 5art 15gm.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Anecream5 Anorectal Cream

Net. Wt. 15g

Distributed by: Focus Health Group

Knoxville, TN 37919

Anecream5 15g Tube Carton

Keep Out of Reach of Children.

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


Structured Label Content

Uses

temporarily relieves pain and itching due to anorectal disorders

Purpose



Local anesthetic

Warnings



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

Other Information (Other information)

Store at USP controlled room temperature 20-25C (66-77F).

Active Ingredient:

Lidocaine 5% w/w

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.



When Using This Product (When using this product)
  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop and Ask A Doctor If (Stop and ask a doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days
Anecream5 15g Tube Carton

AC 5art 15gm.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Anecream5 Anorectal Cream

Net. Wt. 15g

Distributed by: Focus Health Group

Knoxville, TN 37919

Anecream5 15g Tube Carton

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


Advanced Ingredient Data


Raw Label Data

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