Lidocaine HCl 4% by AvPAK / Denison Pharmaceuticals Lidocaine HCl 4%

Lidocaine HCl 4% by

Drug Labeling and Warnings

Lidocaine HCl 4% by is a Otc medication manufactured, distributed, or labeled by AvPAK, Denison Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE HCL 4%- lidocaine hcl 4% cream 
AvPAK

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine HCl 4%

Active Ingredient:

Lidocaine HCl 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to:

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

WARNINGS

For external use only.

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 and ask 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

Directions

• Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
• Children under 2 years of age: Consult a doctor.

Other Information

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Inactive ingredients

benzyl alcohol, carbomer 940, BHT, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

Questions or comments?

1-855-361-3993

Manufactured for:

AvKARE

Pulaski, TN 38478

Lidocaine HCl 4% 10 x 5 g Tube

LIDOCAINE HCL 4% 
lidocaine hcl 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-490-30	1 in 1 CARTON	06/22/2021	01/11/2023
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/22/2021	01/11/2023

Labeler - AvPAK (832926666)

Registrant - Denison Pharmaceuticals (001207208)

Revised: 1/2023

Document Id: f1feda78-c7d3-45ea-e053-2995a90a7df3

34390-5

Set id: 270ed9fb-cbfe-4fad-a2ab-2cef154e1a60

Version: 3

Effective Time: 20230111