RUGBY LIDOCAINE- lidocaine cream 
RUGBY

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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RUGBY® LIDOCAINE 4%

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other information

Inactive ingredients

aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions or comments?

1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Rugby®

Maximum Strength
Lidocaine 4%
Pain and Itch Relief Cream

NDC 0536-1278-03

Compare to the active
ingredient in Gold Bond®
with 4% Lidocaine*

NET WT 0.52 OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
RUGBY LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1278
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGININE (UNII: 94ZLA3W45F)  
SULISOBENZONE (UNII: 1W6L629B4K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ANGOPHORA COSTATA WHOLE (UNII: O5MY197D8F)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1278-031 in 1 CARTON01/17/2020
115 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 FINALpart34801/17/2020
Labeler - RUGBY (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(0536-1278)

Revised: 9/2021
Document Id: 923ea6ed-c59f-4fd4-ade6-9a5f3b64490d
Set id: 836d7525-0e4a-430d-b86d-a6883f1dad63
Version: 2
Effective Time: 20210924
 
RUGBY