TheraPlus

Manufacturer: Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date: 2023-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:57:36

Label at a glance#

ProductTheraPlus Plus

Active ingredientPHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM

Label structure12 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Warnings

WARNINGS SECTION

For external and/or intrarectal use only

OTC - PURPOSE SECTION

Purpose

Protectant

Vasoconstrictor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

-heart disease

-high blood pressure

-thyroid disease

-diabetes

-trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

-presently taking a prescription drug for high blood pressure

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	5
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	5
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55621-005-01	TheraPlus Plus	42 g in 1 TUBE	OINTMENT	42		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55621-005	THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]	5	Current NDC, Legacy NDC, 1 package rows	20231025_edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

TheraPlus Plus
Phenylephrine HCI
YELLOW WAX
BENZOIC ACID
CETYL ALCOHOL
GLYCERIN
LAURETH-23
METHYLPARABEN
PROPYLPARABEN
STEARYL ALCOHOL
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55621-005	55621-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
YELLOW WAX	2ZA36H0S2V	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
LAURETH-23	N72LMW566G	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
MINERAL OIL	T5L8T28FGP	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	AEROSOL, FOAM / TOPICAL	1.08 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	AEROSOL, FOAM / TOPICAL	1.08 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	AEROSOL / TOPICAL	0.45 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	EMULSION / TOPICAL	0.45 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	AEROSOL / TOPICAL	0.45 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURETH-23	LAURETH-23	N72LMW566G	EMULSION / TOPICAL	0.45 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier ndc (package): 55621-005-01 ndc (product): 55621-005 ndc11 (package): 55621000501 spl id: 0884a753-f425-506b-e063-6394a90ac93e spl set id: edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.