FDA Label for Pain Reliveing Patch
View Indications, Usage & Precautions
Pain Reliveing Patch Product Label
The following document was submitted to the FDA by the labeler of this product Anhui Miao De Tang Pharmaceutical Co., Ltd.. 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.
Other
LIDOCAINE PATCH 4%
Otc - Active Ingredient
Lidocaine 4% Topical anesthetic
Otc - Purpose
For the temporary relief of pain
Indications & Usage
LIDOCAINE PATCH to help Temporarily relteves minor pain
Warnings
For external use only
Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor
Otc - Do Not Use
use onlv 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 analcesics
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.
Otc - When Using
use onlv 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 analcesics
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.
lf pregnant or breast-feeding, ask a health professional before use.
Otc - Stop Use
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 where
the product was applied
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).
Dosage & Administration
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.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use.
Storage And Handling
store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredient
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol.
sodium polvacrylate, tartaric acid, poval, alcohol, water
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