THERAPLUS  PLUS- phenylephrine hci ointment 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Drug Facts

beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients

Active Ingredient (in each gram)

Mineral oil  14%

Petrolatum  74.9%

Phenylephrine HCI  0.25%

Warnings

For external and/or intrarectal use only

Purpose

Protectant

Protectant

Vasoconstrictor

. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children


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

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



, ask a health professional before use If pregnant or breast-feeding

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days

-introduction of the applicator into the rectum causes additional pain

Ask a doctor before use if you have

-heart disease

-high blood pressure

-thyroid disease

-diabetes

-trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

-presently taking a prescription drug for high blood pressure

copy of label

THERAPLUS   PLUS
phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-005-0142 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-005)

Revised: 10/2023
Document Id: 0884a753-f425-506b-e063-6394a90ac93e
Set id: edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d
Version: 5
Effective Time: 20231025
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.