Rugby®

Rugby®
SPL v4
SPL
SPL Set ID 836d7525-0e4a-430d-b86d-a6883f1dad63
Route
TOPICAL
Published
Effective Date 2025-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Aloe Vera Leaf Arginine Sulisobenzone Cetyl Alcohol Dimethyl Sulfoxide Angophora Costata Whole Melaleuca Alternifolia Leaf Water Jojoba Oil Sodium Polyacrylate (2500000 Mw) Stearic Acid Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-01-17 Until 2026-05-31

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

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

Section 53414-9

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

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

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

Active Ingredient

Lidocaine 4%

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

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
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)


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

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

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • This package is child-resistant
Inactive Ingredients (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? (Questions or comments?)

1-800-645-2158

Stop Use and Ask A Doctor If (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
Principal Display Panel 15 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)