Label: SOUNDBODY MEDICATED PATCH- camphor, menthol, methyl salicylate patch
- NDC Code(s): 67510-0547-6
- Packager: Kareway Product, 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.
Drug Label Information
Updated February 17, 2023
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- 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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SOUNDBODY MEDICATED PATCH
camphor, menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0547 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) 31 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 60 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 100 mg Inactive Ingredients Ingredient Name Strength PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987) LIQUID PETROLEUM (UNII: 6ZAE7X688J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0547-6 1 in 1 BOX 02/19/2020 1 6 in 1 POUCH; 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 02/19/2002 Labeler - Kareway Product, Inc. (121840057)