SOOTHEE PATCH- lidocaine, menthol, capsaicin, methyl salicylate patch

Soothee Patch by

Drug Labeling and Warnings

Soothee Patch by is a Prescription medication manufactured, distributed, or labeled by Better Pain Solutions, LLC . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHEE PATCH  
lidocaine, menthol, capsaicin, methyl salicylate patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69592-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 mg  in 10 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 10 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 10 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	2 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69592-001-01	15 in 1 BOX
1		10 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2014

Labeler - Better Pain Solutions, LLC (079703680)