RUGBY LIDOCAINE
RUGBY LIDOCAINE 4%
836d7525-0e4a-430d-b86d-a6883f1dad63
HUMAN OTC DRUG LABEL
Sep 16, 2025
Rugby Laboratories
DUNS: 079246066
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
Use
for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
SPL UNCLASSIFIED SECTION
Distributed by:
RUGBY**®**** LABORATORIES**
Livonia, MI 48152
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Lidocaine 4%
OTC - PURPOSE SECTION
Purpose
Topical analgesic
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other information
▪
store at 15 to 30°C (59 to 86°F)
▪
This package is child-resistant
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
1-800-645-2158