FDA Label for Soothee Patch
View Indications, Usage & Precautions
Soothee Patch Product Label
The following document was submitted to the FDA by the labeler of this product Better Pain Solutions, Llc. 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.
Description
ACTIVE INGREDIENTS:
Lidocaine 0.5% External Analgesic
Menthol 5% External Analgesic/Counterirritant
Capsaicin 0.0375% External Analgesic
Methyl Salicylate 2% External Analgesic
Indications & Usage
USES:
Use for temporary relief of minor aches and muscle pains associated with arthritis, simple
backache, strains, sprains, muscle soreness and stiffness
Warnings
WARNINGS:
- For external use only. Use only as directed. Avoid contact with eyes and mucus membranes
- Do not use on wounds or damaged skin
- Stop use and ask a doctor if symptoms persist for more than seven days or clear up and occur again within a few days, or rahs, itching or excessive skin irritation occurs
- Do not cover with bandage
- Do no use if you are allergic to Menthol or Capsaicin
- Consult physician for children under 12
Dosage & Administration
DIRECTIONS:
- Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily
- Children under 12 years, consult a physician before use
- How to apply:
- Clean and dry affected area
- Cut open pouch and remove patch
- If desired, cut patch to size
- Remove protective film and apply directly to area of pain
- Apply to affected area not more than 3 times daily
- Wash hands with soap after applying patch
- Reseal pouch containing unused patches
Inactive Ingredient
INACTIVE INGREDIENTS:
Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe
Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,
Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcabamate,
Propylparaben
Storage And Handling
Store below 77F (25C)
Avoid direct sunlight
Spl Patient Package Insert
Soothee Patch
Better-Rx Manufacturing
The potential exists for a small child or pet to suffer serious
effect from chewing or ingesting a new or used Soothee Patch,
although the risk with this formulation has not been evaluated.
It is important for pateints to store and dispose of Soothee
Patch out of the reach of children, pets and others. (See
HANDLING AND DISPOSAL)
Excessive Dosing
Excessive Dosing by applying Soothee Patch to larger areas for
longer than recommmended wearing time could result in increased absorption and higher blood concentrations. Longer
duration of application, application of more than the
recommended number of patches, smaller patients,
or impaired elimination may all contribute to increasing the blood concentration.
PRECAUTIONS
General
Allergic Reactions
Patients allergic to menthol or capsaicin or any other
ingredient in Soothee Patch should not use the Soothee Patch.
Non-intact Skin
Application tobroken or inflamed skin, although not tested,
may result in higher blood concentrations from increased absorption.
Eye Exposure
The contact of Soothee Patch with eyes, altough not studied, should be avoided
based on the findings of sever eye irritations with the use of similar products in animals.
If eye contact occurs, immediately wash out the eye with water or saline.
Pregnancy
Nursing Mothers
Soothee Patch has not been studied in nursing mothers.
Caution should be exercised when administering the Soothee
Patch to nursing mothers. When soothee patch is used concurrently with other products in the same class
Pediatric Use
Soothee Patch Safety and effectiveness has not been established in pediatric patients.
DOSAGE AND ADMINISTRATION
Apply Soothee Patch to intact skin to cover the area most
sensitive to pain. Apply up to four (4) patches per day. Each
patch should not be applied for more than 8 hours in a given
24-hour period. Patches may be cut into smaller sizes with scissors
prior to removal of the release liner. Clothing may be worn over the area of application.
Smaller areas of treatment are recommended in a debilitated patient, or patient with impaired elimination.
If irritation or a burning sensation occurs during application,
remove the patch and do not reapply until the irritation subsides. When Soothee Patch is used
concomitantly with other products containing same or similar agents, the amount
absorbed from all formulations must be considered.
HANDLING AND DISPOSAL
Hands should be washed after handling Soothee Patch, and eye contact
with Soothee Patch should be avoided. Do not store patch outside the sealed envelope.
Apply immediately after removal from the protective envelope. Fold use patches so that the adhesive
side sticks to itself and safely discard used patches or pieces of cut patches where children and pets
cannot get to them. Soothee Patch should be kept out of reach of children.
HOW SUPPLIED
Soothee Patch (Lidocaine 0.5%/Menthol 5%/Capsaicin
0.0375%/Methyl Salicylate 2%) is available as the following:
Box of 15 patches, packaged into 3 child-resistant envelopes (5
patches /envelope)
Patient Information
Soothee Patch is dispensed by prescription (Rx) under medical supervision and direction
Product Code: 69592-001-01
Better-Rx Manufacturing does not represent this product code to be a National Drug Codes
(NDC). Product Codes are formatted according to standard industry practice, to meet the
formatting requirements of pharmacy and health insurance computer systems.
Store below 77F (25C); excursion permitted to 59-85F (15-30C) See USP Controlled Room Temperature.
Manufactured for:
Better-Rx Manufacturing
122 E Rose Lane No.C Houston Tx 77076
For questions or comments please call 1-800-311-6046
March 2015
Package Label.Principal Display Panel
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