Label: SALONPAS PAIN RELIEVING HOT LARGE- capsaicin patch
- NDC Code(s): 46581-750-01, 46581-750-03, 46581-750-99
- Packager: Hisamitsu Pharmaceutical Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 December 16, 2019
If you are a consumer or patient please visit this version.
- Active ingredient
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
When using this product
- do not use otherwise than as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
Stop use and ask a doctor if
- rash, itching or excessive skin irritation develops
- 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
- peel film from patch and apply to the skin (see illustration)
- apply to affected area not more than 3 to 4 times daily
- remove patch from the skin after at most 8 hours' application
Children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
Questions or comments?
Toll free 1-800-826-8861 www.salonpas.us
Principal Display Panel
Cut open easily by hand
for minor aches and pain relief
- Upper Back
- Lower Back
1 Peel the center film.
2 Place on affected area.
3 Slide a film.
4 Slide the other film.
Salonpas pain relieving PATCH HOT LARGE
Pain Relieving Ointment on a Breathable Cloth
LASTS UP TO 8 HOURS
STRETCHABLE and FLEXIBLE
1 LARGE patch
3 15/16 X 5 1/2 (10cm X 14cm)
Hisamitsu Pharmaceutical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN
Hisamitsu America, Inc.
Florham Park, NJ 07932
INGREDIENTS AND APPEARANCE
SALONPAS PAIN RELIEVING HOT LARGE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46581-750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM SILICATE (UNII: T1FAD4SS2M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46581-750-03 1 in 1 BOX 01/01/2012 1 3 in 1 POUCH 1 2.10 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:46581-750-01 1 in 1 POUCH 01/01/2012 2 2.10 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:46581-750-99 1 in 1 POUCH 01/01/2012 3 2.10 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2012 Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)