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TheraPlus Plus by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Medically reviewed on Mar 9, 2018

Dosage form: ointment
Ingredients: PHENYLEPHRINE HYDROCHLORIDE .25g in 100g, MINERAL OIL 14g in 100g, PETROLATUM 74.9g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-005

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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

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


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

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

THERAPLUS   PLUS
phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 g
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM74.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
BENZOIC ACID 
CETYL ALCOHOL 
GLYCERIN 
LAURETH-23 
METHYLPARABEN 
PROPYLPARABEN 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:55621-005-0142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIOperations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-005)

 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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