Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e3f69b3d-9376-41d6-bc63-a0f5ffc4ad91
Route
TOPICAL
Published
Effective Date 2011-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (80 mg) Menthol (24 mg) Capsicum Oleoresin (16 mg)
Inactive Ingredients
Butylated Hydroxytoluene Carboxymethylcellulose Sodium Edetate Disodium Eucalyptus Oil Isopropyl Myristate Kaolin Magnesium Aluminum Silicate Methylparaben Polysorbate 80 Polyvinyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-12-27

Description

Active Ingredients Purpose Camphor 80mg / patch Topical Analgesic Menthol 24mg / patch Topical Analgesic Capsicum Extract 16mg / patch Topical Analgesic


Medication Information

Warnings and Precautions
Warnings

FOR EXTERNAL USE ONLY

Indications and Usage
Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches
Dosage and Administration

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703



MADE IN KOREA

Description

Active Ingredients Purpose Camphor 80mg / patch Topical Analgesic Menthol 24mg / patch Topical Analgesic Capsicum Extract 16mg / patch Topical Analgesic

Section 44425-7
Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

Section 50565-1


Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
Section 50567-7
When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing
Section 51727-6
Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

Section 51945-4

Section 53414-9


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

Section 55105-1
Uses

For temporary relief of pains.

Section 55106-9
Active Ingredients Purpose
Camphor 80mg / patch Topical Analgesic
Menthol 24mg / patch Topical Analgesic
Capsicum Extract 16mg / patch Topical Analgesic

Structured Label Content

Indications and Usage (34067-9)
Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches
Dosage and Administration (34068-7)

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703



MADE IN KOREA

Warnings and Precautions (34071-1)
Warnings

FOR EXTERNAL USE ONLY

Section 44425-7 (44425-7)
Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

Section 50565-1 (50565-1)


Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
Section 50567-7 (50567-7)
When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing
Section 51727-6 (51727-6)
Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)


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

Section 55105-1 (55105-1)
Uses

For temporary relief of pains.

Section 55106-9 (55106-9)
Active Ingredients Purpose
Camphor 80mg / patch Topical Analgesic
Menthol 24mg / patch Topical Analgesic
Capsicum Extract 16mg / patch Topical Analgesic

Advanced Ingredient Data


Raw Label Data

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