Sinsinpap Cool

Sinsinpap Cool
SPL v5
SPL
SPL Set ID 9d47855f-ccb5-4557-a31a-a2b336fa9806
Routes
TOPICAL CUTANEOUS TRANSDERMAL
Published
Effective Date 2016-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (49.4 mg) Thymol (16.5 mg) Camphor (synthetic) (82.4 mg) Peppermint (164.7 mg) Eucalyptus Oil
Inactive Ingredients
Butylated Hydroxytoluene Castor Oil Glycerin Edetate Disodium Sorbitol Isopropyl Myristate Kaolin Silodrate Methylparaben Peg-4 Stearate Polysorbate 80 Titanium Dioxide Carboxymethylcellulose Sodium, Unspecified Form Sodium Polyacrylate (8000 Mw) Polyvinyl Alcohol, Unspecified Gelatin, Unspecified Tartaric Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-30

Description

L-Menthol 49.4 mg Thymol 16.5 mg DL-Camphor 82.4 mg Mentha Oil 164.7 mg Eucalyptus Oil 16.5 mg

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

L-Menthol 49.4 mg Thymol 16.5 mg DL-Camphor 82.4 mg Mentha Oil 164.7 mg Eucalyptus Oil 16.5 mg

Uses

Temporarily relieves minor pain associated with

  • muscular pain
  • joint pain
  • backache
  • bruise
  • sprain

Warnings

For external use only

Directions
  • Adults and children 12 years of age and over:apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age:do not use, consult a doctor
  • For easy application: partially peel back protective film and apply exposed patch to the site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.
Manufactured By:

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

Storage Condition
  • avoid storing product in direct sunlight
  • store at room temperature
Active Ingredients

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Inactive Ingredients

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Principal Display Panel

When Using This Product:
  • use only as directed
  • do not bandage tightly or use with a healing pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If
  • conditions worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops
Keep Out of Reach of Children.

If swallowed, get medical help from hospital right away


Structured Label Content

Uses

Temporarily relieves minor pain associated with

  • muscular pain
  • joint pain
  • backache
  • bruise
  • sprain

Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 12 years of age and over:apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age:do not use, consult a doctor
  • For easy application: partially peel back protective film and apply exposed patch to the site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.
Manufactured By: (Manufactured by:)

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

Storage Condition (Storage condition)
  • avoid storing product in direct sunlight
  • store at room temperature
Active Ingredients (Active ingredients)

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Inactive Ingredients (Inactive ingredients)

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Principal Display Panel

When Using This Product: (When using this product:)
  • use only as directed
  • do not bandage tightly or use with a healing pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help from hospital right away


Advanced Ingredient Data


Raw Label Data

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