NDC | 36800-188-16 |
Set ID | 51521353-a859-4d6b-84eb-6523e780989c |
Category | HUMAN OTC DRUG LABEL |
Packager | Topco Associates LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- Active ingredients
- Purposes
-
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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
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
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
TOPCARE HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-188 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140.000 mg in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749.000 mg in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.500 mg in 100 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) COD LIVER OIL (UNII: BBL281NWFG) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SQUALANE (UNII: GW89575KF9) THYME OIL (UNII: 2UK410MY6B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-188-16 1 in 1 CARTON 1 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/22/2013 Labeler - Topco Associates LLC (006935977)