NDC | 51452-727-01 |
Set ID | 7107e22e-9332-4509-b368-32296acb5648 |
Category | HUMAN OTC DRUG LABEL |
Packager | Fabrication Enterprises |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- USES
-
WARNINGS
- For External use only. Use only as directed.
- Avoid contact with eyes and mucous membranes.
- If symptoms persist for more than 7 days, discontinue use and consult a physician
- If swallowed, consult a physician.
-
DIRECTIONS
- Apply to treatment area.
- How to apply:
- Clean and dry treatment area.
- If customized size is needed, cut patch to the desired size/shape with scissors.
- Remove protective backing from patch to expose active ingredient and adhesive.
- Apply patch to treatment area.
- Use only one patch at a time. Use a maximum of four patches per day.
- Leave patch on treatment area for up to 12 hours.
- Do not use patches for longer than 5 consecutive days.
-
OTHER INGREDIENTS
Water, Glycerol, Sodium polyacrylate, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Aluminiumglycinate, Titaniumdioxide, Kaolin, Tween 80, Propylene glycol, Tartaric acid, PVP, Polyacrylic acid, Methylparaben, Propylparaben.
- STORAGE AND HANDLING
- Representative Labeling
-
INGREDIENTS AND APPEARANCE
POINT RELIEF LIDOSPOT
lidocaine hcl, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-727 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TARTARIC ACID (UNII: W4888I119H) PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461) POLYSORBATE 80 (UNII: 6OZP39ZG8H) KAOLIN (UNII: 24H4NWX5CO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-727-01 5 in 1 POUCH 03/02/2016 1 8 g in 1 PATCH; 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 03/02/2016 Labeler - Fabrication Enterprises (070577218)