asperflex (lidocaine 4% ointment)

asperflex (lidocaine 4% ointment)
SPL v3
SPL
SPL Set ID d22c8c01-1ba2-e9d3-e053-2995a90ac4f0
Route
topical
Published
Effective Date 2024-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
polysorbate 80 phenoxyethanol water mineral oil white petrolatum aloe vera whole

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2024-09-13

Purpose

Topical Analgesic

Description

Lidocaine HCL 4%


Medication Information

Warnings

For external use only

Uses

Temporarily relieves minor pain & itching due to:

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

Topical Analgesic

Directions
  • adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Other Information
  • for topical use only
  • do not use in the eyes
  • Store are room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

aloe vera, mineral oil, petrolatum white, phenoxyethanol, polysorbate 80, purified water.

Description

Lidocaine HCL 4%

Section 50565-1

Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • symptoms presist for more than seven days or clear up and occur again within a few days
  • Condition worsens
  • localized skin reactions occur such as rash, pain, itching, readness, irritation, swelling or blistering
Section 50567-7

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
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

Maximun Strength

NDC 71399-6544-1

AsperFlex™

Touch on Pain

Lidocaine 4% Ointment

Pain reliving Formula

Topical Analgesic

Numbs Away Pain

Made in the USA

NET WT 3.53 OZ (100g)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Active Ingredient

Lidocaine HCL 4%

Questions Or Comments?

Call toll-free 1-877-255-6999

Childproof Packaging

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

Visit at: www.akronpharma.com


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves minor pain & itching due to:

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

Topical Analgesic

Directions
  • adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Other Information (Other information)
  • for topical use only
  • do not use in the eyes
  • Store are room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

aloe vera, mineral oil, petrolatum white, phenoxyethanol, polysorbate 80, purified water.

Section 50565-1 (50565-1)

Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms presist for more than seven days or clear up and occur again within a few days
  • Condition worsens
  • localized skin reactions occur such as rash, pain, itching, readness, irritation, swelling or blistering
Section 50567-7 (50567-7)

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
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)

Maximun Strength

NDC 71399-6544-1

AsperFlex™

Touch on Pain

Lidocaine 4% Ointment

Pain reliving Formula

Topical Analgesic

Numbs Away Pain

Made in the USA

NET WT 3.53 OZ (100g)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Active Ingredient (Active ingredient)

Lidocaine HCL 4%

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-255-6999

Childproof Packaging

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

Visit at: www.akronpharma.com


Advanced Ingredient Data


Raw Label Data

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