Label: THERAPLUS PLUS- phenylephrine hci ointment
- NDC Code(s): 55621-005-01
- Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- Warnings
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
DOSAGE & ADMINISTRATION
Directions
adults and children 12 years of age and older for topical use:
-clean the affected area, and oat 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
- PREGNANCY OR BREAST FEEDING
- STOP USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
THERAPLUS PLUS
phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-005 Route of Administration TOPICAL 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:55621-005-01 42 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 03/01/2013 Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549) Establishment Name Address ID/FEI Business Operations Zhejiang Jingwei Pharmaceutical Co., Ltd. 530876549 manufacture(55621-005)