Tempocool

Tempocool
SPL v6
SPL
SPL Set ID bd642389-6d03-4e09-a71c-312fb90eae89
Route
TOPICAL
Published
Effective Date 2018-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 mg) Camphor (natural) (1 mg)
Inactive Ingredients
Glycerin Sodium Polyacrylate (2500000 Mw) Citric Acid Monohydrate Tartaric Acid Polysorbate 80 Carboxymethylcellulose Sodium (0.9 Carboxymethyl Substitution Per Saccharide; 600 Mpa.s At 2%) Edetate Disodium Polyacrylic Acid (800000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-20

Description

Children suffering from high temperature or fever Adults suffering from headache and migrain

Purpose

Children suffering from high temperature or fever Adults suffering from headache and migrain


Medication Information

Purpose

Children suffering from high temperature or fever Adults suffering from headache and migrain

Description

Children suffering from high temperature or fever Adults suffering from headache and migrain

Carton

Dosage
  • One sheet for 8 hours.
Storage
  • Store in a cool dry place.
  • Avoid direct sunlight.
Warnings
  • FOR EXTERNAL USE ONLY
  • Tempo cool has no side effects and used safely with all medications.
  • Avoid contacts with eyes.
  • Do not bandage tightly.
  • Do not apply to wound or damaged skin
Directions
  • Peel off the transparent layer,attach Sheet to the forehead area or back of the neck.
Purpose Section
  • Children suffering from high temperature or fever
  • Adults suffering from headache and migrain
Stop Use and Ask Doctor
  • If condition worsens
Active Ingredient Section

Menthol 0.3 %

Camphor. 1%

Inactive Ingredient Section

Glycerin ,Sodium polyacrylate , Anhydrous citric acid  ,Tartaric acid ,Poly sorbate -80 (tween 80) ,

EDETA ,Water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right a way


Structured Label Content

Carton

Dosage
  • One sheet for 8 hours.
Storage
  • Store in a cool dry place.
  • Avoid direct sunlight.
Warnings
  • FOR EXTERNAL USE ONLY
  • Tempo cool has no side effects and used safely with all medications.
  • Avoid contacts with eyes.
  • Do not bandage tightly.
  • Do not apply to wound or damaged skin
Directions
  • Peel off the transparent layer,attach Sheet to the forehead area or back of the neck.
Purpose Section
  • Children suffering from high temperature or fever
  • Adults suffering from headache and migrain
Stop Use and Ask Doctor (Stop use and ask doctor)
  • If condition worsens
Active Ingredient Section (Active Ingredient section)

Menthol 0.3 %

Camphor. 1%

Inactive Ingredient Section (Inactive Ingredient section)

Glycerin ,Sodium polyacrylate , Anhydrous citric acid  ,Tartaric acid ,Poly sorbate -80 (tween 80) ,

EDETA ,Water.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right a way


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)