FDA Label for Pro Comfort 8 Hours Patch
View Indications, Usage & Precautions
- PRODUCT INFORMATION
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- MANUFACTURED FOR:
- DOSAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pro Comfort 8 Hours Patch Product Label
The following document was submitted to the FDA by the labeler of this product Care Living Diagnostics Inc. 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.
Product Information
Active Ingredient
Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purpose
Topical Anesthetic
Uses
for the temporary relief of pain
Warnings
For external use only
Do not use
- more than 1 patch on your body at a time
- on puncture wounds,
- on cuts, irritated or swollen skin
- for more than one week without consulting a doctor
- use only as directed. Read and follow all directions and warnings on this carton.
- do not allow contact with the eyes
- 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
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness or irritation develops
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
- wish and dry affected area
- Peel off the backing fim from one side of the patch carefully
- Apply the exposed portion of the patch to the affected area
- Gently press the patch with your hand to fit the affected area completely
- Do not exercise vigorously during use to prevent the patch from falling off
- use only 1 patch for a maximum of 8 hours
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Adults and children over 12 years:
children under 12 years of age: Ask a doctor before use
Other Information
store at room temperature 15°-30°C (59°-86°F).
Inactive ingredients
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water
Questions or Comments?
E-mail: [email protected]
Child-Resistant Packaging
Manufactured for
CARE LIVING DIAGNOSTICS INC.
Www.carelivingusa.com
Made in China
Active Ingredient
Lidocaine 4%
Purpose
Topical anesthetic
Uses
for the temporary relief of pain
Warnings
For external use only
Do Not Use
- more than 1 patch on your body at a time
- on puncture wounds,
- on cuts, irritated or swollen skin
- for more than one week without consulting a doctor
When Using This Product
- use only as directed. Read and follow all directions and warnings on this carton.
- do not allow contact with the eyes
- 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
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness or iritation develops
- you experience signs of skin injury, such as pain, swelling, or blistering wherethe product was applied
If Pregnant Or Breast-Feeding,
ask a health professional before use
Keep Out Of Reach Of Children And Pets.
lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)
Directions
Adults and children 12 years of age and older:
- Wash and dry the affected area.
- Peel off the backing film from one side of the patch carefully.
- Apply the exposed portion of the patch to the affected area.
- Gently press the patch with your hand to fit the affected area completely.
- Do not exercise vigorously during use to prevent the patch from falling off.
- Ues only 1 patch for a maximum of 8 hours.
children under 12 years of age:Ask a doctor before use.
Other Information
store at room temperature 15°-30°C (59°-86°F).
Inactive Ingredients
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water
Questions Or Comments?
E-mail:[email protected]
Manufactured For:
CARE LIVING DIAGNOSTICSINC
www.carelivingusa.com
Made in China
Dosage
0.246 g in 1 PATCH,5 PATCH in 1 CARTON
Package Label.Principal Display Panel
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