Active Ingredient
Lidocaine 4%
Salonpas Lidocaine Pain Relieving Patch
FDA Label NDC 55328-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hisamitsu America, Inc. for the product Salonpas Lidocaine Pain Relieving (NDC 55328-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Uses
For temporary relief of pain
Warnings
For external use only
Do Not Use
● more than 1 patch at a time
● on wounds or damaged skin
● with a heating pad
● if you are allergic to any ingredients of this product
When Using This Product
● use only as directed
● avoid contact with the eyes, mucous membranes or rashes
● do not bandage tightly
Stop Use And Ask A Doctor If
● localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
● conditions worsen
● symptoms persist for more than 7 days
● symptoms clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over:
● clean and dry affected area
● remove film from patch and apply to the skin (see illustration)
● apply 1 patch at a time to affected area, not more than 3 to 4 times daily
● remove patch from the skin after at most 8-hour application
Children under 12 years of age: consult a doctor
Other Information
● Avoid storing product in direct sunlight
● Protect product from excessive moisture
Inactive Ingredients
aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxyde, water
Questions Or Comments?
Toll free 1-800-826-8861 www.salonpas.us
Principal Display Panel
OTC topical analgesics in patch category*
WORLD'S BRAND NO.1
Hisamitsu
NDC#55328-100-02
Desensitize aggravated nerves
for temprary relief of pain
● Back
● Neck
● Shoulders
● Knees & Elbows
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
● Numbing Relief
● Unscented
2 PATCHES
3 15/16'' X 5 1/2'' (10cm X 14cm)
Image Of 2-patch Box Label (5532810002 1)
OTC topical analgesics in patch category*
WORLD'S BRAND NO.1
Hisamitsu
NDC#55328-100-06
Desensitize aggravated nerves
for temprary relief of pain
● Back
● Neck
● Shoulders
● Knees & Elbows
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
● Numbing Relief
● Unscented
6 PATCHES
3 15/16'' X 5 1/2'' (10cm X 14cm)
Image Of 6-patch Box Label (5532810006 1)
OTC topical analgesics in patch category*
WORLD'S BRAND NO.1
Hisamitsu
NDC#55328-100-15
Desensitize aggravated nerves
for temprary relief of pain
● Back
● Neck
● Shoulders
● Knees & Elbows
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
● Numbing Relief
● Unscented
15 PATCHES
3 15/16'' X 5 1/2'' (10cm X 14cm)
Image Of 15-patch Box Label (5532810015 1)
NOW 30 PATCHES
Hisamitsu
NDC#55328-100-30
Desensitize aggravated nerves
for temprary relief of pain
● Back
● Neck
● Shoulders
● Knees & Elbows
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
● Numbing Relief
● Unscented
30 PATCHES
3 15/16'' X 5 1/2'' (10cm X 14cm)
Image Of 30-patch Box Label (5532810030 1)
CUT OPEN HERE
Hisamitsu
NDC#55328-100-01
HOW TO APPLY
Fold sides back, pull apart to expose adhesive.
Place on affected area.
Peel off one side of the film.
Peel off the remaining film.
Press and smooth patch to secure.
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
● Numbing Relief
● Unscented
1 PATCH
3 15/16'' X 5 1/2'' (10cm X 14cm)
Scan for HOW TO APPLY Video
Image Of 1-patch Pouch Label (5532810001 1)
* Please review the disclaimer below.
