Otc - Active Ingredient
Active Ingredient:
Topical Starch
Warm Sap Patch
FDA Label NDC 50387-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by E-house Korea Holdings International for the product Warm Sap Patch (NDC 50387-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - when using, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, warnings, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - When Using
When using this product:- Do not use other than directed- Do not stretch the adhesive portion- Do not remove the patch's contents- Discard patch if ripped
Otc - Do Not Use
Do Not Use:- on wounds or damaged skin- if allergic to any of this product's ingredients- With or at the same time as other external products
Otc - Stop Use
Stop Use and Consult Medical Professional- if allergic reaction or irritation occurs- if pregnant, nursing or under medical treatment
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center immediately
Storage And Handling
Avoid storing product in direct sunlight. Keep it in a dry and cool place.
Warnings
For external use only
Description
How To Use:Apply to arches of the feet, center of the hands, toes and fingers since many of the main bodily organs connect at these locations. The patch may be used at any time but is usually most convenient just prior to bed. For localized treatment, place the patch on any aching, sprained or sore area.
Inactive Ingredient
Inactive Ingredients:Chitosan, Micro Capsule, Polysaccharide, Agaricus, Mugwort Extract, Vitamin C, Loquat Extract, Tourmaline, Eucalyptus Oil
Dosage & Administration
Directions:Adults and children over 4 yearsStep 1: Clean and dry area for the patch to be attachedStep 2: Remove the protective cover sheet and gently applyStep 3: Leave it on at least 4 hours before removalChildren under 4 years, consult your medical professional
* Please review the disclaimer below.
