Label: SALONPAS LIDOCAINE PAIN RELIEVING- lidocaine patch
- NDC Code(s): 46581-830-01, 46581-830-02, 46581-830-06, 46581-830-15
- Packager: Hisamitsu Pharmaceutical Co., Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 19, 2020
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- Active ingredient
For external use only
Do not use
- more than one patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any igredients 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, irritaion, pain, swelling and blistering
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
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 to affected are 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
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
Principal Display Panel
CUT OPEN HERE
HOW TO APPLY
1 Pull apart.
2 Peel off one side of the film.
3 Place on affected area.
4 Peel off the remaining film.
5 Press patch thoroughly.
Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch
APPLY FOR 8 HOURS
3 15/16" X 5 1/2" (10cm X 14cm)
MADE IN JAPAN
INGREDIENTS AND APPEARANCE
SALONPAS LIDOCAINE PAIN RELIEVING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46581-830 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 560 mg Inactive Ingredients Ingredient Name Strength ALUMINUM SILICATE (UNII: T1FAD4SS2M) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) OLEIC ACID (UNII: 2UMI9U37CP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46581-830-06 6 in 1 BOX 08/01/2016 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:46581-830-02 2 in 1 BOX 10/01/2017 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:46581-830-15 15 in 1 BOX 08/01/2017 3 1 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:46581-830-01 1 in 1 POUCH; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2016 Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)