Label: CAPSIMIDE- capsaicin 0.025% topical patch patch
- NDC Code(s): 70512-016-10
- Packager: Sola Pharmaceuticals
- 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 September 7, 2022
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- Active Ingredients
- Do not use
When using this product
- use only as directed
- read and follow all directions and warnings on this carton
- do not allow contact with the eyes
- do not sue at the same time as other topical analgesics
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not microwave
- dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep our of reach of children
- Other Information
- Other Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
capsaicin 0.025% topical patch patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70512-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) WATER (UNII: 059QF0KO0R) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70512-016-10 10 in 1 BOX 09/07/2022 1 9 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/07/2022 Labeler - Sola Pharmaceuticals (080121345)