Rugby®

Rugby®
SPL v101
SPL
SPL Set ID fcf48536-224e-4a3d-9124-770031823972
Route
TOPICAL
Published
Effective Date 2011-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Cetostearyl Alcohol Dimethicone Glycerin Methylparaben Polysorbate 60 Propylparaben Sodium Hydroxide Sodium Lauryl Sulfate Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-11

Description

Drug Facts

How Supplied

NDC: 72162-2156-2: 85 g in a TUBE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

How Supplied

NDC: 72162-2156-2: 85 g in a TUBE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Drug Facts

Use

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

  • arthritis
  • simple backache
  • strains
  • 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 right away.

Section 51945-4

Pain Relieving Cream

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Menthol 1.0% Topical Analgesic
Methyl Salicylate 15.0% Topical Analgesic
Warnings

For external use only

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor.
Do Not Use
  • immediately after shower or bath
  • with a heating pad
  • on wounds, damaged, broken or irritated skin
Other Information

Store at room temperature 15° - 30°C (59°F – 86°F).

Inactive Ingredients

Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions Or Comments?

1-800-645-2158

When Using This Product
  • use only as directed
  • do not swallow
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
Stop and Ask A Doctor If
  • skin redness or irritation develops
  • condition worsens or pain lasts for more than 7 days

Structured Label Content

Use

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

  • arthritis
  • simple backache
  • strains
  • 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 right away.

Section 51945-4 (51945-4)

Pain Relieving Cream

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Menthol 1.0% Topical Analgesic
Methyl Salicylate 15.0% Topical Analgesic
Warnings

For external use only

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor.
Do Not Use (Do not use)
  • immediately after shower or bath
  • with a heating pad
  • on wounds, damaged, broken or irritated skin
How Supplied (HOW SUPPLIED)

NDC: 72162-2156-2: 85 g in a TUBE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

Store at room temperature 15° - 30°C (59°F – 86°F).

Inactive Ingredients (Inactive ingredients)

Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions Or Comments? (Questions or comments?)

1-800-645-2158

When Using This Product (When using this product)
  • use only as directed
  • do not swallow
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
Stop and Ask A Doctor If (Stop and ask a doctor if)
  • skin redness or irritation develops
  • condition worsens or pain lasts for more than 7 days

Advanced Ingredient Data


Raw Label Data

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