NDC | 50804-126-05 |
Set ID | 7585d111-775f-4fb6-a485-28cd99d88852 |
Category | HUMAN OTC DRUG LABEL |
Packager | Geiss, Destin and Dunn, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- open pouch and remove patch
- carefully peel off protective backing and apply sticky side to affected area
- adults and children 12 years of age or older
- do not wear patch for more than 8 hours
- apply to affected area no more than 3 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg Inactive Ingredients Ingredient Name Strength SORBITAN MONOOLEATE (UNII: 06XEA2VD56) KAOLIN (UNII: 24H4NWX5CO) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-126-05 1 in 1 CARTON 12/26/2018 1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/26/2018 Labeler - Geiss, Destin and Dunn, Inc. (076059836)