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

Description

Lidocaine 4% w/w

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4% w/w

Uses

temporarily relieves pain and itching due to

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

Warnings

For external use only

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

Lidocaine 4% w/w

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

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

Uses

temporarily relieves pain and itching due to

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

Purpose

Topical anesthetic

Warnings

For external use only

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.
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

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

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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