1451 Cold/hot Medictaed Patches Arm/neck 67777-201-10

1451 Cold/hot Medictaed Patches Arm/neck 67777-201-10
SPL v5
SPL
SPL Set ID 999881b3-287e-d975-e053-2995a90a87e3
Route
TOPICAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (285 mg)
Inactive Ingredients
Edetate Disodium Castor Oil Polysorbate 80 Isopropyl Myristate Polyvinyl Alcohol, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water Glycerin Polyacrylic Acid (250000 Mw) Dihydroxyaluminum Aminoacetate Propylene Glycol Urea Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-13

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

Temporarily relieves minor aches and pains of muscles and joints due to

  • Arthritis
  • Simple backache
  • Strains
  • Sprains
  • Bruises
Label

Cold Hot Medicated Patch 1450

Warnings

For external use only

Directions

Adults and children 12 years of age and over

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • Wear each patch up to 8 hours maximum

Children under 12 years of age, consult a doctor

Do Not Use
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Active Ingredient

Menthol 5%

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate Dihydrate, Glycerol, Isopropyl Myristate, Polyacrylic Acid (250000 MW), Polysorbate 80, Polyvinyl Alcohol, Propylene Glycol, Silicon Dioxide, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water

Questions and Comments?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If
  • Excessive redness or irritation is present
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
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 (1-800-222-1222) right away.


Structured Label Content

Use

Temporarily relieves minor aches and pains of muscles and joints due to

  • Arthritis
  • Simple backache
  • Strains
  • Sprains
  • Bruises
Label

Cold Hot Medicated Patch 1450

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • Wear each patch up to 8 hours maximum

Children under 12 years of age, consult a doctor

Do Not Use (Do not use)
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Active Ingredient

Menthol 5%

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate Dihydrate, Glycerol, Isopropyl Myristate, Polyacrylic Acid (250000 MW), Polysorbate 80, Polyvinyl Alcohol, Propylene Glycol, Silicon Dioxide, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water

Questions and Comments?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Excessive redness or irritation is present
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)