Your browser does not support JavaScript! TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]
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TOPCARE HEMORRHOIDAL (cocoa butter, phenylephrine hcl) suppository
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient (in each suppository)

Cocoa butter 85.39%

Phenylephrine HCl 0.25%

Purpose

Protectant

Vasoconstrictor

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporarily relieves burning and shrinks hemorrhoidal tissue
temporarily provides a coating for relief of anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For rectal use only

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

When using this product

do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

bleeding occurs
condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
hold suppository with rounded end up
see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
remove exposed suppository from wrapper
insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
children under 12 years of age: ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, methylparaben, propylparaben, shark liver oil

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

NIGHTTIME RELIEF

Hemorrhoidal Suppositories

REDUCES INTERNAL SWELLING. SOOTHES AND PROTECTS.

Prompt soothing relief from painful burning, itching and discomfort

Shrinks swollen hemorrhoidal tissue

Protects irritated tissue

E-Z OPEN WRAPPER

COMPARE TO PREPARATION H® HEMORRHOIDAL SUPPOSITORIES active ingredients

Hemorrhoidal Suppositories Carton Image 1
Hemorrhoidal Suppositories Carton Image 2
TOPCARE HEMORRHOIDAL 
cocoa butter, phenylephrine hcl suppository
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-115
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER2.135 g  in 2.5 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE.0065 g  in 2.5 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
METHYLPARABEN 
PROPYLPARABEN 
SHARK LIVER OIL 
Product Characteristics
ColorYELLOWScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-115-532 in 1 CARTON
115 g in 1 BLISTER PACK
2NDC:36800-115-624 in 1 CARTON
215 g in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/28/2012
Labeler - Topco Associates LLC (006935977)

Revised: 3/2013
 
Topco Associates LLC

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