Label: SALONPAS PAIN RELIEF- menthol, methyl salicylate patch
- NDC Code(s): 46581-675-01, 46581-675-09, 46581-675-99
- Packager: Hisamitsu Pharmaceutical Co., Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 15, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each patch)
- Purpose
- Uses
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Warnings
For external use only
Stomach bleeding warning:
This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- on the face or rashes
- on wouds or damaged skin
- if allergic to aspirin or other NSAIDs
- with a heating pad
- when sweating (such as from exercise or heat)
- any patch from a pouch that has been open for 14 or more days
- right before or after heart surgery
Ask a doctor before use if
- you are allergic to topical products
- the stomach bleeding warning applies to you
- you are taking a diuretic
- you have high blood pressure, heart disease, or kidney disease
When using this product
- wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- stomach pain or upset gets worse or lasts
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding.
- rash, itching or skin irritaion develops
- condition worsens
- symptoms last for more than 3 days
- symptoms clear up and occur again within a few days
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Directions
Adults 18 years and older:
- only use one patch at a time
- clean and dry affected area
- remove patch from backing film and apply to skin (see illustration)
- apply one patch to the affected area and leave in place for up to 8 to 12 hours
- if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
- do not use more than 2 patches per day
- do not use for more than 3 days in a row
- the used patch should be removed from the skin when a new one is applied
Children under 18 years of age: do not use; this product has not been shown to work in children
- Other information
- Inactive inredients
- Questions or comments?
-
Principal Display Panel
LARGE
3 15/16" X 5 1/2"
Hisamitsu
NDC#46581-675-09
for temporary relief of mild to moderate painBackache
Sore Muscle
Sprains
Bruises
Salonpas
Pain Relief Patch
APPLY FOR 8 - 12 HOURS
Menthol 3%
Methyl Salicylate 10%
Topical Analgesic
FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH
EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL
9 LARGE PATCHES
3 15/16" X 5 1/2" (10cm X 14cm)
Package not child resistant.
Keep out of reach of children.
*DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.
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Principal Display Panel
CUT OPEN HERE
NDC#46581-675-01
HOW TO APPLY
1 Peel the center film.
2 Place on affected area.
3 Slide a film.
4 Slide the other film.Salonpas
Pain Relief PatchAPPLY FOR 8 - 12 HOURS
Menthol 3%
Methyl Salicylate 10%Topical Analgesic
FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH
EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL1 LARGE PATCH
3 15/16" X 5 1/2" (10cm X 14cm)*DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.
Hisamitsu
Package not child resistant.
Keep out of reach of children.Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
408, Tashirodaikan-machi, Tosu, Saga, JapanDistributed by
Hisamitsu America, Inc.
Florham Park, NJ 07932MADE IN JAPAN
-
Principal Display Panel
LARGE
3 15/16" X 5 1/2"
Hisamitsu
NDC#46581-675-99
for temporary relief of mild to moderate painBackache
Sore Muscle
Strains
Bruises
HOW TO APPLY
1 Peel the center film.
2 Place on affected area.
3 Slide a film.
4 Slide the other film.
Salonpas
Pain Relief Patch
APPLY FOR 8 - 12 HOURS
Menthol 3%
Methyl Salicylate 10%
Topical Analgesic
FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH
EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL
1 LARGE PATCH
3 15/16" X 5 1/2" (10cm X 14cm)
Package not child resistant.
Keep out of reach of children.
*DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.
Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN
Distributed by
Hisamitsu America, Inc.
Florham Park, NJ 07932
FREE SAMPLE
NOT FOR RE-SALE
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INGREDIENTS AND APPEARANCE
SALONPAS PAIN RELIEF
menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46581-675 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 63 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 210 mg Inactive Ingredients Ingredient Name Strength ALUMINUM SILICATE (UNII: T1FAD4SS2M) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46581-675-09 3 in 1 BOX 06/01/2018 1 3 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:46581-675-01 1 in 1 POUCH; Type 0: Not a Combination Product 08/01/2020 3 NDC:46581-675-99 1 in 1 POUCH; Type 0: Not a Combination Product 05/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022029 06/01/2018 Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)