Label: PURE-AID- camphor, menthol, methyl salicylate patch
- NDC Code(s): 67510-0289-1, 67510-0289-2
- 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 June 5, 2018
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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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PURE-AID
camphor, menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0289 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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 41.73 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 69.55 mg Inactive Ingredients Ingredient Name Strength PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) LIQUID PETROLEUM (UNII: 6ZAE7X688J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0289-1 1 in 1 BOX 06/05/2018 1 10 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67510-0289-2 1 in 1 BOX 06/05/2018 2 20 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 06/05/2018 Labeler - Kareway Product, Inc. (121840057)