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Topcare hemorrhoidal by Topco Associates LLC

Medically reviewed on August 28, 2017

Dosage form: ointment
Ingredients: MINERAL OIL 140.000mg in 100g, PETROLATUM 749.000mg in 100g, PHENYLEPHRINE HYDROCHLORIDE 2.500mg in 100g
Labeler: Topco Associates LLC
NDC Code: 36800-188

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.

Topco Associates LLC. Hemorrhoidal Ointment Drug Facts

Active ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Protectant

Vasoconstrictor

Uses

•helps relieve the local itching and discomfort associated with hemorrhoids

•temporarily shrinks hemorrhoidal 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

Warnings

For external and/or intrarectal 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
introduction of applicator into the rectum causes additional pain

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 applying ointment.
when first opening the tube, puncture foil seal with top end of cap
apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
also apply ointment to external area
regular use provides continual therapy for relief of symptoms
children under 12 years of age: ask a doctor

Other information
store at 20-25oC (68-77oF)

Inactive ingredients

bees wax, butylated hydroxytoluene, cod liver oil, glycerin, lanolin, methylparaben, paraffin wax, propylparaben, purified water, sodium benzoate, squalane, thyme oil, tocopherol acetate

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

MEDICATED
Hemorrhoidal Ointment

PREVENTS FURTHER IRRITATION

Prompt, soothing relief from painful burning, itching and discomfort

Shrinks swollen hemorrhoidal tissue

Protects irritated tissue

Relieves internal and external discomfort

COMPARE TO PREPARATION H® HEMORRHOIDAL OINTMENT active ingredients

TOPCARE HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-188
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL140.000 mg  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM749.000 mg  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.500 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
COD LIVER OIL 
GLYCERIN 
LANOLIN 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
WATER 
SODIUM BENZOATE 
SQUALANE 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-188-161 TUBE in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/22/2013
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

← See all Topcare hemorrhoidal brands

Further information

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

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