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NDC 46581-0670-15 Salonpas Pain Relief 31.5; 105 mg/1; mg/1 Details
Salonpas Pain Relief 31.5; 105 mg/1; mg/1
Salonpas Pain Relief is a PERCUTANEOUS; TOPICAL; TRANSDERMAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Hisamitsu Pharmaceutical Co., Inc.. The primary component is MENTHOL; METHYL SALICYLATE.
Product Information
| NDC | 46581-0670 |
|---|---|
| Product ID | 46581-670_34749e27-1251-4cca-9ad3-b4b2b0f06767 |
| Associated GPIs | |
| GCN Sequence Number | 064937 |
| GCN Sequence Number Description | methyl salicylate/menthol ADH. PATCH 10 %-3 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 18333 |
| HICL Sequence Number | 002583 |
| HICL Sequence Number Description | METHYL SALICYLATE/MENTHOL |
| Brand/Generic | Brand |
| Proprietary Name | Salonpas Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Menthol, Methyl Salicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | PERCUTANEOUS; TOPICAL; TRANSDERMAL |
| Active Ingredient Strength | 31.5; 105 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | MENTHOL; METHYL SALICYLATE |
| Labeler Name | Hisamitsu Pharmaceutical Co., Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022029 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 46581-0670-15 (46581067015)
| NDC Package Code | 46581-670-15 |
|---|---|
| Billing NDC | 46581067015 |
| Package | 3 POUCH in 1 BOX (46581-670-15) / 5 PATCH in 1 POUCH |
| Marketing Start Date | 2008-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2 Details
Active ingredients (in each patch)
Uses
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
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
Hisamitsu
NDC#46581-670-05
for temporary relief of mild to moderate pain
Sore Muscle
Sprains
Backache
Joint Pain
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
5 PATCHES
2 3/4" X 3 15/16" (7cm X 10cm)
Package not child resistant.
Keep out of reach of children.
*DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.
Principal Display Panel
Hisamitsu
FREE SAMPLE
NOT FOR RE-SALE
minty scent
NDC#46581-670-99
for temporary relief of mild to moderate pain
Sore Muscle
Sprains
Backache
Joint Pain
1 Peel the center film.
2 Place on affected area.
3 Slide the film forward.
4 Slide the other film backward.
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 patch
2 3/4" X 3 15/16" (7cm X 10cm)
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 Pharmacetuical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN
Disributed by
Hisamitsu America, Inc.
Florham Park, NJ 07932
Principal Display Panel
Hisamitsu
NDC#46581-670-06
for temporary relief of mild to moderate pain
Sore Muscle
Sprains
Backache
Joint Pain
BONUS PACK!
ONE FREE PATCH
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
6 patches
2 3/4" X 3 15/16" (7cm X 10cm)
Package not child resistant.
Keep out of reach of children.
*DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.
INGREDIENTS AND APPEARANCE
| SALONPAS PAIN RELIEF
menthol, methyl salicylate patch |
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| Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713) |