Label: CAPSAICIN HEAT- capsaicin patch
- NDC Code(s): 52000-040-40, 52000-040-41
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
-
WARNINGS:
EXTERNAL USE ONLY
DO NOT USE
• on wounds or damaged skin
• with a heating pad
• with or at the same times as other external analgesic
• if you are allergic to any ingredients of this productWhen using this product
• do not use otherwise than as directed.
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or showerSTOP 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 few daysIf pregnant or breast-feeding, ask a health professional before use.
- DIRECTIONS
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
CAPSAICIN HEAT
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-040 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 GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) WATER (UNII: 059QF0KO0R) POVIDONE K90 (UNII: RDH86HJV5Z) TARTARIC ACID (UNII: W4888I119H) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-040-41 1 in 1 BOX 03/07/2019 1 NDC:52000-040-40 2 in 1 POUCH 1 3.28 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/07/2019 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Koolcare Technology Co., Ltd. 602479389 manufacture(52000-040)