Menthopatch Hot

Menthopatch Hot
SPL v6
SPL
SPL Set ID 3d289be3-c237-4065-a8ac-e8c2e51b76a5
Route
TOPICAL
Published
Effective Date 2018-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsicum (50 mg) Menthol (40 mg)
Inactive Ingredients
Glycerin Sodium Polyacrylate (2500000 Mw) Aluminum Chloride Anhydrous Citric Acid Monohydrate Tartaric Acid Polysorbate 80 Isopropyl Myristate Carboxymethylcellulose Sodium (0.9 Carboxymethyl Substitution Per Saccharide; 600 Mpa.s At 2%) Edetate Disodium Polyacrylic Acid (800000 Mw) Water Titanium Dioxide Methyl Salicylate Camphor (natural) Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-25

Description

Menthol 4%  Capsicum  Extract  5 % 

Purpose

Temporarily relieves minor pain.


Medication Information

Purpose

Temporarily relieves minor pain.

Description

Menthol 4%  Capsicum  Extract  5 % 

Carton

Storage
  • Store in cool dry place avoid direct sunlight.
Warnings
  • For external use only
  • When using this product
  • Avoid contact with the eyes
  • Do not apply to wounds, or to damaged skin
  • Do not bandage tightly.
  • Consult doctor if pain continued after 7 days using product or excess skin inflamation.
  • Children under 12 years of age: consult doctor.
Purpose 

Temporarily relieves minor pain.

Direction 
  • Clean and dry the affected area.
  • Open the cover of product and peel of the transparent layer of the product.
  • Paste the product on affected area.
  • Menthol patch is effective up to 8 hours which can replaced as needed.
Active Ingrdient

Menthol 4% 

Capsicum  Extract  5 % 

Inactive Ingredients

Glycerin 24 

Sodium poly acryl ate 8 

Aluminum chloride hexahydrate 

Citric acid 

Tartaric acid 

Polysorbate 80

Isopropyl myristate alcohol 2.5 

Car boxy methyl cellulose 

EDETA .2Na 0.5 

Polyvinyl pyrolidone(PVP-K90) 

Water 48

Titanium dioxide 

Methyl salicylate 

Camphor 

Hot act vbe 0.2

ACRYLATE/ C10-30 ALKYL ACRYLATE cross polymer

Dosage & Administration
  • use menthol patch from 2 to 3 days
Stop Use and Ask Doctor
  • If condition worsens
  • If symptoms persist more than 7 days or clear up and occur again with a few days
Keep Out of Reach of Children

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


Structured Label Content

Carton

Storage
  • Store in cool dry place avoid direct sunlight.
Warnings
  • For external use only
  • When using this product
  • Avoid contact with the eyes
  • Do not apply to wounds, or to damaged skin
  • Do not bandage tightly.
  • Consult doctor if pain continued after 7 days using product or excess skin inflamation.
  • Children under 12 years of age: consult doctor.
Purpose 

Temporarily relieves minor pain.

Direction 
  • Clean and dry the affected area.
  • Open the cover of product and peel of the transparent layer of the product.
  • Paste the product on affected area.
  • Menthol patch is effective up to 8 hours which can replaced as needed.
Active Ingrdient

Menthol 4% 

Capsicum  Extract  5 % 

Inactive Ingredients (Inactive ingredients)

Glycerin 24 

Sodium poly acryl ate 8 

Aluminum chloride hexahydrate 

Citric acid 

Tartaric acid 

Polysorbate 80

Isopropyl myristate alcohol 2.5 

Car boxy methyl cellulose 

EDETA .2Na 0.5 

Polyvinyl pyrolidone(PVP-K90) 

Water 48

Titanium dioxide 

Methyl salicylate 

Camphor 

Hot act vbe 0.2

ACRYLATE/ C10-30 ALKYL ACRYLATE cross polymer

Dosage & Administration (DOSAGE & ADMINISTRATION)
  • use menthol patch from 2 to 3 days
Stop Use and Ask Doctor (Stop use and ask doctor)
  • If condition worsens
  • If symptoms persist more than 7 days or clear up and occur again with a few days
Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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