Label: SALONPAS- camphor, menthol, methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 63629-8310-1 - Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 46581-110
- 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.
Drug Label Information
Updated February 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Allergy alert:
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALONPAS
camphor, menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-8310(NDC:46581-110) 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) 21.56 mg MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 41.73 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 69.55 mg Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) ALUMINUM SILICATE (UNII: T1FAD4SS2M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-8310-1 20 in 1 POUCH; Type 0: Not a Combination Product 02/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2015 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-8310) , RELABEL(63629-8310)