Asper Flex Cream
FDA Label NDC 71399-0049

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Asper Flex (NDC 71399-0049). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, directions, for external use only, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Directions

→ For External Use Only

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

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

Warnings

For external use only

Otc - Do Not Use

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

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.

For External Use Only

Do Not Use

in or near the eyes
in large quantities, particularly over raw or blistered areas

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.

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].