SPL v3
SPL
SPL Set ID 1025b986-a1e5-701d-e063-6294a90a33fd
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (240 mg)
Inactive Ingredients
Povidone Paraffinum Liquidum Carboxymethylcellulose Sodium Aluminium Sulfate Octadecahydrate Borax Propylene Glycol Dihydroxyaluminum Aminoacetate Butylated Hydroxytoluene Water Sodium Polyacrylate (8000 Mw) Sorbitan Monooleate Polyacrylic Acid (250000 Mw) Titanium Dioxide Aluminum Hydroxide Polyvinyl Alcohol (100000 Mw) Alpha-tocopherol Acetate Tartaric Acid Kaolin Dmdm Hydantoin Glycerin Edetate Disodium

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Menthol 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains

Dosage and Administration

Topical Pain Relief Patch of External Use Only

Description

Menthol 5%

Section 44425-7

Store at room temperature 20-25 0C (68-77 0F)

Section 50565-1

keep out of reach of children and pets

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

Section 50567-7
  • use only as directed.
  • read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin
  • do not allow contact with eyes and mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets
  • used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if a severe burning sensation occurs, discontinue use immediately.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.
Section 50569-3
  • condition worsens
  • redness is present over the affected area
  • excess skin irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury such as pain, swelling, or blistering where the product was applied
Section 50570-1
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds or damaged skin
  • for more than one week without consulting a doctor
  • with heating pad
  • on a child under 12 yeas of age with arthritis-like conditions
Section 51727-6

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Section 51945-4

Section 53413-1

Call +91-905-677-0088

Section 53414-9

if pregnanat or breast feeding, ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 5%

Section 59845-8

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
  • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • do not wear a patch for more than 8 hours
  • apply affected area no more than 3 times daily

children 12 years or younger:

  • ask a doctor

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains

Dosage and Administration (34068-7)

Topical Pain Relief Patch of External Use Only

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store at room temperature 20-25 0C (68-77 0F)

Section 50565-1 (50565-1)

keep out of reach of children and pets

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

Section 50567-7 (50567-7)
  • use only as directed.
  • read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin
  • do not allow contact with eyes and mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets
  • used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if a severe burning sensation occurs, discontinue use immediately.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.
Section 50569-3 (50569-3)
  • condition worsens
  • redness is present over the affected area
  • excess skin irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury such as pain, swelling, or blistering where the product was applied
Section 50570-1 (50570-1)
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds or damaged skin
  • for more than one week without consulting a doctor
  • with heating pad
  • on a child under 12 yeas of age with arthritis-like conditions
Section 51727-6 (51727-6)

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call +91-905-677-0088

Section 53414-9 (53414-9)

if pregnanat or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 5%

Section 59845-8 (59845-8)

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
  • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • do not wear a patch for more than 8 hours
  • apply affected area no more than 3 times daily

children 12 years or younger:

  • ask a doctor

Advanced Ingredient Data


Raw Label Data

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