NDC | 55621-006-01 |
Set ID | bfa195d7-d87f-43b5-bbf1-7ec3a451de05 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses - Helps relieve the local itching and discomfort associated with hemorrhoids.
-Temporarily shrinks hemorrhoid tissue and relieves burning
-Temporarily provides a coating for relief of anorectal discomforts
-Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements
less painful
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and older for topical use:
-clean the affected area, and pat or dab dry before applying ointment
-apply to the affected area up to 4 times daily, especially after each bowel movement.
For intrarectal use:
-attach included applicator to tube
-lubricate applicator tip and gently insert into rectum
-thoroughly clean applicator after each use and replace cover.
Children under 12 years of age: ask a doctor before use.
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
phenylephrine hci, petrolatum, mineral oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-006 Route of Administration TOPICAL, RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BENZOIC ACID (UNII: 8SKN0B0MIM) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55621-006-01 1 in 1 BOX 11/01/2013 1 57 g in 1 TUBE; 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 11/01/2013 Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549) Establishment Name Address ID/FEI Business Operations Zhejiang Jingwei Pharmaceutical Co., Ltd. 530876549 manufacture(55621-006)