FDA Label for Dr Sabharwals
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - ASK DOCTOR
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- OTC - QUESTIONS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Dr Sabharwals Product Label
The following document was submitted to the FDA by the labeler of this product Dr. Sabharwal's Wound Care. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Menthol 5%
Otc - Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains
Warnings
For external use only
Otc - Do Not Use
- 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
Otc - When Using
- 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.
Otc - Ask Doctor
- 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
Otc - Pregnancy Or Breast Feeding
if pregnanat or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
keep out of reach of children and pets
if swallowed, get medical help or contact a Poison Control Center right away
Instructions For Use
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
- ask a doctor
children 12 years or younger:
Storage And Handling
Store at room temperature 20-25 0C (68-77 0F)
Otc - Questions
Call +91-905-677-0088
Inactive Ingredient
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.
Dosage & Administration
Topical Pain Relief Patch of External Use Only
* Please review the disclaimer below.