FDA Label for Pain Relief Lidocaine
View Indications, Usage & Precautions
Pain Relief Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar. 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.
Otc - Active Ingredient
Active ingredientPurpose
Lidocaine 4%.................................................... Topical anesthetic
Otc - Purpose
Use
■ temporarily relieves minor pain
Warnings
For external use only
Otc - Do Not Use
Do not use
■ more than 1 patch on your body at a time or on cut, irritated or
swollen skin ■ at the same time as other topical analgesics
■ on puncture wounds
■ for more than one week without consulting a doctor
Otc - When Using
When using this product
■ use only as directed. Read and follow all directions and
warnings on this label. ■ do not allow contact with the eyes
■ do not bandage tightly or apply local heat (such as heating
pads) to the area of use
■ discontinue use at least 1 hour before a bath or shower
■ do not use immediately after a bath or shower
■ dispose of used patch in manner that always keeps product
away from children or 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 - Stop Use
Stop use and ask a doctor if
■ condition worsens ■ redness is present
■ symptoms persist for more than 7 days or clear up and occur
again within a few days ■ irritation develops
■ you experience signs of skin injury, such as pain, swelling, or
blistering where the product was applied
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before
use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
■ adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and
gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch and
apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully
remove remaining backing to completely apply patch to
affected area ■ use 1 patch for up to 12 hours
■ children 12 years or younger: ask a doctor
Storage And Handling
Other information
■ store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients alcohol, aluminum glycinate, glycerin,
kaolin, methylparaben, polysorbate 80, propylparaben, purified
water, sodium polyacrylate, tartaric acid, titanium dioxide
Dosage & Administration
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105
MADE IN CHINA
* Please review the disclaimer below.
