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TheraPlus

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Drug Facts




FULL PRESCRIBING INFORMATION

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



Purpose

Purpose

Protectant

Protectant

Vasoconstrictor

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


Uses

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

TheraPlus

Phenylephrine HCI OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55621-005
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE .25 g
Mineral Oil 14 g
petrolatum 74.9 g

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
BENZOIC ACID
CETYL ALCOHOL
GLYCERIN
laureth-23
METHYLPARABEN
PROPYLPARABEN
stearyl alcohol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55621-005-01 42 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2013-03-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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