Label: CAPSAICIN PAIN RELIEF- capsaicin patch
- NDC Code(s): 67510-0303-1, 67510-0303-2
- 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.
Updated June 7, 2018
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- Active ingredient
For external use only.
Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
Do not use
- on wounds or damaged skin
- with a heating pad
- with, or at the same times as other external analgesic products
- 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
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
- Other information
- Inactive ingredients
- Package label
INGREDIENTS AND APPEARANCE
CAPSAICIN PAIN RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.702 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) LIQUID PETROLEUM (UNII: 6ZAE7X688J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0303-1 1 in 1 CARTON 01/23/2012 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67510-0303-2 2 in 1 POUCH; Type 0: Not a Combination Product 05/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/23/2012 Labeler - Kareway Product, Inc. (121840057)