NDC | 69379-037-20 |
Set ID | 17261c31-21aa-5e21-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Home Aide Diagnostics, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
-
WARNINGS
WARNINGS
- Do not get into eyes or on mucous membranes
- Do not apply to wounds, damaged or irritated skin
- Do not bandage or cover with any type of wrap except clothing
- Do not use with a heating pad or apply external heat
- Do not use in large quantities, particularly over raw surfaces or blistered areas
- This product may cause allergic reaction in some individuals
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
DOSAGE & ADMINISTRATION
DIRECTIONS
- Store below 25 oC (77 oF). Avoid direct sunlight
- Clean and dry affected area
- Remove patch from backing and apply to affected area
- Use only one patch at a time and maximum of four patches daily
- Leave patch on affeted area for up to 8-hours
- Do not use patch for longer than 5 consecutive days unless directed by a physician
- Children under 12 years of age should consult a physician prior to use
- INACTIVE INGREDIENT
- PURPOSE
-
INGREDIENTS AND APPEARANCE
SILVERA PAIN RELIEF PATCH
silvera pain relief patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69379-037 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 1 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength BORNEOL (UNII: M89NIB437X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69379-037-20 5 in 1 BOX 1 3 in 1 PACKAGE 1 100 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 05/28/2015 Labeler - Home Aide Diagnostics, Inc. (783518983)