NDC | 69379-041-01 |
Set ID | 19c1dbe5-db74-3e91-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Home Aide Diagnostics, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
DOSAGE & ADMINISTRATION
DIRECTIONS
- 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 affected area for up to 8-hours
- Do not use patches for longer than 5 consecutive days unless directed by a physician.
- Store below 25 °C (77 °F). Avoid direct sunlight.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REMATEX
rematex pain relievingcream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69379-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69379-041-01 120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2015 Labeler - Home Aide Diagnostics, Inc. (783518983) Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875) Establishment Name Address ID/FEI Business Operations Zhejiang Bangli Medical Products Co. Ltd 421295875 manufacture(69379-041)