Label: SALONPAS DEEP RELIEVING- camphor, menthol, methyl salicylate gel
- NDC Code(s): 55328-900-02
- Packager: Hisamitsu America, 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 November 28, 2018
If you are a consumer or patient please visit this version.
- Active ingredients
For external use only
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Keep away from fire or flame.
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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
Stop use and ask a doctor if
- conditions worsen
- skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- Other information
- Inactive ingredients
Questions or comments?
Toll free 1-800-826-8861
- Principal Display Panel
INGREDIENTS AND APPEARANCE
SALONPAS DEEP RELIEVING
camphor, menthol, methyl salicylate gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55328-900 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.10 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10.00 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15.00 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55328-900-02 1 in 1 BOX 06/01/2013 1 78 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2013 Labeler - Hisamitsu America, Inc. (191877802)