Rugby 5% Menthol Hot/cold Patch

Rugby 5% Menthol Hot/cold Patch
SPL v7
SPL
SPL Set ID c68d29c2-9b56-4994-e053-2a95a90ae60e
Route
TOPICAL
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (5 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Mineral Oil Glycerin Kaolin Methylparaben Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Petrolatum Povidone, Unspecified Propylparaben Tartaric Acid Titanium Dioxide Water Carboxymethylcellulose Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Purpose

Topical analgesic


Medication Information

Indications and Usage

Targeted, long-lasting pain relief

Purpose

Topical analgesic

Description

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

Questions

Call 1-800-645-2158



Directions

Directions Adults and children 12 years of age and over:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • wear one patch up to 8 hours
  • repeat as necessary, but no more than 3 times daily
  • discard patch after single use
  • reseal pouch after opening.
  • Children under 12 years of age: consult a physician.
Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Inactive Ingredients

CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

When Using This Product

■ use only as directed

■ Rare cases of serious burns have been reported with products of this type

■ don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ do not use at the same time as other topical analgesics

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Keep Out of Reach of Children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Stop Use and Consult A Doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Rugby Menthol Cold / Hot Patch


Structured Label Content

Indications and Usage (34067-9)

Targeted, long-lasting pain relief

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Topical analgesic

Warnings

For external use only

Questions

Call 1-800-645-2158



Directions

Directions Adults and children 12 years of age and over:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • wear one patch up to 8 hours
  • repeat as necessary, but no more than 3 times daily
  • discard patch after single use
  • reseal pouch after opening.
  • Children under 12 years of age: consult a physician.
Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Inactive Ingredients

CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

When Using This Product (When using this product)

■ use only as directed

■ Rare cases of serious burns have been reported with products of this type

■ don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ do not use at the same time as other topical analgesics

Other Safety Information (Other safety information)

Store at room temperature, not to exceed 86F (30C)

Keep Out of Reach of Children (Keep out of reach of children)

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Stop Use and Consult A Doctor (Stop use and consult a doctor)

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Rugby Menthol Cold / Hot Patch


Advanced Ingredient Data


Raw Label Data

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