FARGELIN HEMORRHOIDAL- calamine, petrolatum and phenylephrine hydrochloride ointment 
MADISON ONE ACME INC

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Drug Facts

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

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

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
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
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 and ask a doctor if
condition worsens
symptoms do 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.

Directions

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

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

FARGELIN HEMORRHOIDAL OINTMENT

NDC 55614-610-01

0.705 oz (20 g)
box-02.jpg

FARGELIN HEMORRHOIDAL 
calamine, petrolatum and phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-610
Route of AdministrationTOPICAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.3 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.05 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM79.25 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-610-0120 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product11/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart34611/27/2019
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-610)

Revised: 11/2024
Document Id: a3184f2e-2b37-4b3e-8983-b031e8f6b7ef
Set id: 6844ad63-512d-496a-9458-011894185b0d
Version: 5
Effective Time: 20241125
 
MADISON ONE ACME INC