RUGBY LIDOCAINE- lidocaine cream

RUGBY LIDOCAINE by

Drug Labeling and Warnings

RUGBY LIDOCAINE by is a Otc medication manufactured, distributed, or labeled by RUGBY, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

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
17177 N Laurel Park Drive,
Suite 233
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)

INGREDIENTS AND APPEARANCE

RUGBY LIDOCAINE 
lidocaine cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/17/2020

Labeler - RUGBY (079246066)

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