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NDC 00536-1278-03 RUGBY LIDOCAINE 40 mg/g Details

RUGBY LIDOCAINE 40 mg/g

RUGBY LIDOCAINE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY. The primary component is LIDOCAINE.

Product Information

NDC	00536-1278
Product ID	0536-1278_923ea6ed-c59f-4fd4-ade6-9a5f3b64490d
Associated GPIs	90850060003720
GCN Sequence Number	040262
GCN Sequence Number Description	lidocaine CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	95405
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Generic
Proprietary Name	RUGBY LIDOCAINE
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	RUGBY
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1278-03 (00536127803)

Pricing Information
NDC Package Code	0536-1278-03
Billing NDC	00536127803
Package	1 TUBE in 1 CARTON (0536-1278-03) / 15 g in 1 TUBE
Marketing Start Date	2020-01-17
NDC Exclude Flag	N
Price Per Unit	0.70753
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	LIDOCAINE 4% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 836d7525-0e4a-430d-b86d-a6883f1dad63 Details

SPL UNCLASSIFIED SECTION

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

store at 15 to 30°C (59 to 86°F)
This package is child-resistant

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

RUGBY LIDOCAINE

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1278
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1278-03	1 in 1 CARTON	01/17/2020
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/17/2020

Labeler - RUGBY (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(0536-1278)

Revised: 9/2021

Document Id: 923ea6ed-c59f-4fd4-ade6-9a5f3b64490d

Set id: 836d7525-0e4a-430d-b86d-a6883f1dad63

Version: 2

Effective Time: 20210924

Search by Drug Name or NDC

NDC 00536-1278-03 RUGBY LIDOCAINE 40 mg/g Details

RUGBY LIDOCAINE 40 mg/g

Product Information

Package

Package Images

NDC 00536-1278-03 (00536127803)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 836d7525-0e4a-430d-b86d-a6883f1dad63 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

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