anecream 4%

anecream 4%
SPL v13
SPL
SPL Set ID 2d7706e2-7363-4047-96cb-85b718277e8c
Route
topical
Published
Effective Date 2019-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
benzyl alcohol water carbomer homopolymer type c cholesterol lecithin, soybean polysorbate 80 propylene glycol .alpha.-tocopherol acetate, dl- trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2007-06-01

Purpose

Topical anesthetic

Description

Lidocaine 4% w/w


Medication Information

Warnings

For external use only.

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Purpose

Topical anesthetic

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Inactive Ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

Description

Lidocaine 4% w/w

Anecream 30g Tube

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

Anecream Topical Anesthetic Cream

Net. Wt. 30g

Distributed by: Focus Health Group

Knoxville, TN 37919

Active Ingredient:

Lidocaine 4% w/w

When Using This Product
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask Doctor If
  • Allergic reaction 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
Keep Out of Reach of Children.

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


Structured Label Content

Warnings (WARNINGS)

For external use only.

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Purpose

Topical anesthetic

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

Anecream 30g Tube

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

Anecream Topical Anesthetic Cream

Net. Wt. 30g

Distributed by: Focus Health Group

Knoxville, TN 37919

Active Ingredient:

Lidocaine 4% w/w

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Allergic reaction 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
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

All Sections (JSON)