Label: FARGELIN HEMORRHOIDAL- calamine, petrolatum and phenylephrine hydrochloride ointment
- NDC Code(s): 55614-610-01
- Packager: MADISON ONE ACME INC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated November 22, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.
- FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily.
- children under 12 years of age: consult a doctor.
- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FARGELIN HEMORRHOIDAL
calamine, petrolatum and phenylephrine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-610 Route of Administration TOPICAL, RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10.3 g in 100 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 0.05 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 79.25 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength AMBER (UNII: 70J9Z0J26P) CALLICARPA NUDIFLORA LEAF (UNII: IRA5LS3VXW) CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z) LANOLIN (UNII: 7EV65EAW6H) PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U) PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) SODIUM BORATE (UNII: 91MBZ8H3QO) STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-610-01 20 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 11/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/27/2019 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(55614-610)