asper flex (lidocaine 4% cream)

asper flex (lidocaine 4% cream)
SPL v4
SPL
SPL Set ID 06ddae64-cda7-4eb9-872f-5182c83cb00c
Route
topical
Published
Effective Date 2025-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
aloe barbadensis leaf benzyl alcohol carbomer cetostearyl alcohol cholesterol glycerin isopropyl myristate polysorbate 80 propylene glycol water stearic acid tocopherol trolamine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-01-06

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
  • minor burns
  • sunburn
  • minor skin irritation
  • insect bites
Purpose

Topical anesthetic

Directions
  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.
Other Information
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cetostearyl alcohol, Cholesterol, Glycerin, lsopropyl myristate, Polysorbate 80, Propylene Glycol, Purified Water, Stearic acid, Tocopherol, Trolamine

Description

Lidocaine 4% w/w

Section 50570-1

Do not use

  • if you are allergice to any active or inactive ingredients of this product
  • on wonds or damaged, irritated, or sensitive skin
  • with any other topical anesthetic
  • for more than one week without constulting a doctor
  • over large areas of the body
Section 51945-4

Do Not Use
  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas
Active Ingredient

Lidocaine 4% w/w

For External Use Only

Questions Or Comments?

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, NJ 07004

www.akronpharma.com

Stop Use and Ask A 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

For external use only

Uses

temporarily relieves pain and itching due to

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

Topical anesthetic

Directions
  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.
Other Information (Other information)
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cetostearyl alcohol, Cholesterol, Glycerin, lsopropyl myristate, Polysorbate 80, Propylene Glycol, Purified Water, Stearic acid, Tocopherol, Trolamine

Section 50570-1 (50570-1)

Do not use

  • if you are allergice to any active or inactive ingredients of this product
  • on wonds or damaged, irritated, or sensitive skin
  • with any other topical anesthetic
  • for more than one week without constulting a doctor
  • over large areas of the body
Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas
Active Ingredient (Active ingredient)

Lidocaine 4% w/w

For External Use Only (For external use only)

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, NJ 07004

www.akronpharma.com

Stop Use and Ask A Doctor If (Stop use and ask a 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. (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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