NDC | 57483-410-12, 57483-410-13 |
Set ID | 8a885822-42e7-44e0-82d6-fa967123866e |
Category | HUMAN OTC DRUG LABEL |
Packager | Innovus Pharmaceuticals, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- Active ingredients
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breastfeeding
- Keep out of reach of children
-
Directions
-Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a toilet tissue or a soft cloth.
-remove the wrapper before inserting into the rectum.
-insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.
-Children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
- Purpose
- Carton Label
-
INGREDIENTS AND APPEARANCE
XYRALID HEMORRHOIDAL
hemorrhoidal suppositories suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-410 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 88.5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.26 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) 0.02 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.02 g in 100 g MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.2 g in 100 g Product Characteristics Color white Score Shape BULLET Size 32mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-410-13 4 in 1 CARTON 03/25/2018 1 NDC:57483-410-12 24 g in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/25/2018 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(57483-410)