Active Ingredient
Lidocaine HCL 4%
Lidocaine
FDA Label NDC 71399-6544
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 Lidocaine (NDC 71399-6544). 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, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporarily relieves minor pain & itching due to:
- minor cuts
- minor scrapes
- sunburn
- minor skin irritations
- minor burns
- 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
Otc - When Using
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
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
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.
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.
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
Package Label.Principal Display Panel
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)
* Please review the disclaimer below.
