Lidocaine 4% Cream by Rugby Laboratories / Teligent, Inc. Drug Facts

Lidocaine 4% Cream by

Drug Labeling and Warnings

Lidocaine 4% Cream by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Teligent, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE 4% CREAM- lidocaine cream 
Rugby Laboratories

----------

Drug Facts

Active ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Keep

Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Temporarily relieves pain due to:

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

Warnings

For external use only.

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas.

When Using

this product

  • keep out of eyes
  • use only as directed.

Stop Use

and ask doctor if

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor.

Inactive Ingredients

butylated hydroxytoluene, cetostearyl alcohol, citric acid, edetate disodium, light mineral oil, methylparaben, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium citrate, and white petrolatum.

Questions?

Call 1-800-645-2158

RETAIN CARTON FOR COMPLETE DRUG FACTS

To open, push down cap while turning counter-clockwise and lift off.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

See crimp of tube for Lot No. and Exp. Date

Distributed bu:

RUGBY LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rev. 12/19

R-170

Re-order No. 370992

Insert

LIDOCAINE 4% Cream

DESCRIPTION

Lidocaine 4% cream is a non-greasy cream specially formulated with soothing agents, indicated as a topical anesthetic for use on normal intact skin for local analgesia and itching due to minor cuts, minor scrapes, sunburn, minor skin irritations, minor burns and insect bites.

INGREDIENTS

ACTIVE: Lidocaine (4%)

INACTIVE: Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and White Petrolatum.

The chemical designation of Lidocaine is 2-(diethylamino)-N(2,6-dimethylphenyl), acetamide. The structure of lidocaine is:

structural formula

MECHANISM OF ACTION

Lidocaine 4% cream applied to intact skin provides dermal analgesia by the release of lidocaine from the cream into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions through the neuronal membrane. The onset, depth and duration of dermal analgesia provided depend upon the site and duration of application.

INDICATIONS AND USAGE

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.

Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.

CONTRAINDICATIONS

Lidocaine 4% cream is contraindicated in patients with sensitivity to amide type local anesthetics or to any component of the product.

WARNINGS

For external use only. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than seven days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inappropriate use of this product, such as on large areas of the body, application on mucous membranes, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended.

PRECAUTIONS

Repeated doses of lidocaine 4% cream may increase blood levels of lidocaine. Avoid contact with the eyes. If eye contact occurs, immediately wash out the eye with water or saline.

The patient should be aware that dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned.

DRUG INTERACTIONS

Lidocaine 4% cream should be used with caution in patients receiving Class I antiarrhythmic agents (e.g., tocainide, mexiletine) since the toxic effects are potentially additive and synergistic.

DIRECTIONS

  • Adults 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.

HOW SUPPLIED

NDC: 0536-1281-28 (30 gram tubes)

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

Manufactured by:

Teligent Pharma, Inc.

Buena, New Jersey 08310

Distributed by:

RUGBY LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

C101500

Revised 01/2020

Package/Label Principal Display Panel

Rugby®

NDC: 0536-1281-28

Lidocaine Cream 4%

Net Wt. 30 grams

For Topical Use Only

Do Not Use in the Eyes

4.0% carton
LIDOCAINE 4% CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1281
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1281-281 in 1 CARTON03/13/202008/31/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/13/202008/31/2023
Labeler - Rugby Laboratories (079246066)

Revised: 11/2024
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.