Lidocaine by Akron Pharma Inc. LIDOCAINE ointment

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCL 4%

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

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

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

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

PREGNANCY OR BREAST FEEDING

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

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

Drug Facts

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)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-6544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)

Product Characteristics
Color	white (clear gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-6544-1	1 in 1 JAR; Type 0: Not a Combination Product	09/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	09/13/2024

Labeler - Akron Pharma Inc. (067878881)