Label: CAPSAICIN patch
- NDC Code(s): 71436-3025-1
- Packager: ARI BRANDS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only. Use only as directed or as directed by a health care professional
Read all warnings and directions before use.
Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.
Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes
Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.
When using this product
• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• Avoid contact with the eyes, lips, nose and mucous membranes
• Do not tightly wrap or bandage the treated area
• Do not apply heat to the treated area immediately before or after use
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Directions
Adults and children 18 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPSAICIN
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71436-3025 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 WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LEMON OIL (UNII: I9GRO824LL) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) EUCALYPTUS OIL (UNII: 2R04ONI662) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71436-3025-1 2 in 1 BOX 10/01/2023 1 5 in 1 POUCH 1 100 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 10/01/2023 Labeler - ARI BRANDS, LLC (080658382)