THERAPLUS PLUS- phenylephrine hci ointment

TheraPlus by

Drug Labeling and Warnings

TheraPlus by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

ACTIVE INGREDIENT

Active Ingredient (in each gram)

Mineral oil  14%

Petrolatum  74.9%

Phenylephrine HCI  0.25%

Warnings

For external and/or intrarectal use only

PURPOSE

Purpose

Protectant

Protectant

Vasoconstrictor

KEEP OUT OF REACH OF CHILDREN

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

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

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

STOP USE

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

-presently taking a prescription drug for high blood pressure

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPLUS   PLUS
phenylephrine hci ointment

Product 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 final	part346	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)