Rugby®

Rugby®
SPL v5
SPL
SPL Set ID 2b65cb6a-4364-4770-b7b9-5c4637edd01a
Route
TOPICAL
Published
Effective Date 2024-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (20 mg)
Inactive Ingredients
Ammonia Fd&c Blue No. 1 Carboxymethylcellulose Sodium, Unspecified Cupric Sulfate Isopropyl Alcohol Magnesium Sulfate Anhydrous Sodium Hydroxide Thymol Water

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-20

Description

Drug Facts

Purpose

Pain relieving gel


Medication Information

Purpose

Pain relieving gel

Description

Drug Facts

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
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 immediately.

Section 53414-9

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

Warnings

For external use only

Directions
  • Clean affected area before applying product.
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor.
Do Not Use
  • with other topical pain relievers.
  • with heating pads or other heating devices.
Active Ingredient

Menthol 2.0%

Other Information
  • store at room temperature 20 to 25°C (68 to 77°F)
  • Keep lid tightly closed.
  • Do not use, pour, spill or store near heat or open flame.
Inactive Ingredients

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Questions Or Comments?

1-800-645-2158

When Using This Product
  • do not use in or near the eyes.
  • do not apply to wounds or damaged skin.
  • do not bandage tightly.
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • redness or irritation develops.
Principal Display Panel 226.8 G Jar Label

Rugby ® NDC 0536-1061-39

Blue Gel

External Analgesic

Pain Relieving Gel for Minor

Aches and Pains of Muscles

and Joints

COMPARE TO ACTIVE INGREDIENT

IN MINERAL ICE®*

NET WT 8 OZ

(226.8 g)


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
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 immediately.

Section 53414-9 (53414-9)

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

Purpose

Pain relieving gel

Warnings

For external use only

Directions
  • Clean affected area before applying product.
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor.
Do Not Use (Do not use)
  • with other topical pain relievers.
  • with heating pads or other heating devices.
Active Ingredient (Active ingredient)

Menthol 2.0%

Other Information (Other information)
  • store at room temperature 20 to 25°C (68 to 77°F)
  • Keep lid tightly closed.
  • Do not use, pour, spill or store near heat or open flame.
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Questions Or Comments? (Questions or comments?)

1-800-645-2158

When Using This Product (When using this product)
  • do not use in or near the eyes.
  • do not apply to wounds or damaged skin.
  • do not bandage tightly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • redness or irritation develops.
Principal Display Panel 226.8 G Jar Label (PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label)

Rugby ® NDC 0536-1061-39

Blue Gel

External Analgesic

Pain Relieving Gel for Minor

Aches and Pains of Muscles

and Joints

COMPARE TO ACTIVE INGREDIENT

IN MINERAL ICE®*

NET WT 8 OZ

(226.8 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)