RUGBY LIDOCAINE- lidocaine cream 
Rugby Laboratories

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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Drug Facts

Active ingredient

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses

Warnings

For external use only

Do not use

  • on large areas of the body or on cut,irritated or swollen skin
  • on puncture wounds
  • for more than one week without consultanting a doctor

When using this product

use only as directed. read and follow all directions and warnings on this carton.

do notallow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask a doctor if

  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children and pets.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Other information

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

Questions?(800)645-2158

Principal Panel-Tube

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

Principal Panel-Tube

Principal Panel - Carton

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

Principal Panel - Carton

RUGBY LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON (UNII: Z4152N8IUI)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-21 (UNII: 53J3F32P58)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1139-201 in 1 CARTON09/21/2018
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0536-1139-281 in 1 CARTON11/27/2018
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/21/2018
Labeler - Rugby Laboratories (079246066)

Revised: 1/2021
Document Id: b20041bc-3ba5-46c3-9f4c-c290d6b9567c
Set id: 56b4b8e9-ab92-4635-b9ec-aa6f5390101f
Version: 3
Effective Time: 20210114
 
Rugby Laboratories