FARGELIN HEMORRHOIDAL- calamine, petrolatum and phenylephrine hydrochloride ointment

FARGELIN HEMORRHOIDAL by

Drug Labeling and Warnings

FARGELIN HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Calamine 10.5%
Petrolatum 79.25%
Phenylephrine hydrochloride 0.25%

PURPOSE

Purpose
Hemorrhoidal (anorectal) astringent/protectant
Hemorrhoidal (anorectal) protectant
Hemorrhoidal (anorectal) vasoconstrictor

INDICATIONS & USAGE

Uses
temporarily helps relieve:

     anorectal burning, itching, and discomfort associated with hemorrhoids
temporarily:

     reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

     shrinks hemorrhoidal tissue

     protects inflamed perianal skin and irritated areas

WARNINGS

Warnings
For rectal use only

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

WHEN USING

When using this product
in case of bleeding; consult a doctor promptly

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

do not use with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

STOP USE

Stop use and ask a doctor if
condition worsens
symptoms do not improve within 7 days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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.

STORAGE AND HANDLING

Other information
keep container tightly closed

store at room temperature 20 - 25 C (68 - 77 F)

do not use if the physical properties of this product have changed

INACTIVE INGREDIENT

Inactive ingredients Amber, callicarpa nudiflora leaf, corydalis yanhusuo tuber, lanolin, panax notoginseng root, pearl, sanguisorba officinalis root, scutellaria baicalensis root, sodium borate, and styphnolobium japonica flower.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

PRINCIPAL DISPLAY PANEL

FARGELIN HEMORRHOIDAL OINTMENT

NDC: 55614-610-01

0.705 oz (20 g)

INGREDIENTS AND APPEARANCE

FARGELIN HEMORRHOIDAL 
calamine, petrolatum and phenylephrine hydrochloride ointment

Product 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)