drug facts

Composition & Product

Active Ingredients

zinc oxide (10.3 g) ferric oxide red (0.05 g) petrolatum (79.25 g) phenylephrine (0.25 g)

Inactive Ingredients

amber callicarpa nudiflora leaf corydalis yanhusuo tuber lanolin panax notoginseng root pearl (hyriopsis cumingii) sanguisorba officinalis root scutellaria baicalensis root sodium borate styphnolobium japonicum flower

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2019-11-27

Medication Information

Warnings and Precautions

Warnings

For rectal use only

Active Ingredient

Active ingredients

Calamine 10.5%

Petrolatum 79.25%

Phenylephrine hydrochloride 0.25%

Indications and 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

Dosage and 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.

Description

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

Section 44425-7

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

condition worsens

symptoms do not improve within 7 days

Section 50567-7

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are 

presently taking a prescription drug for high blood pressure or depression

Section 50569-3

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

Section 51727-6

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.

Section 51945-4

FARGELIN HEMORRHOIDAL OINTMENT

NDC 55614-610-01

0.705 oz (20 g)

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Hemorrhoidal (anorectal) astringent/protectant

Hemorrhoidal (anorectal) protectant

Hemorrhoidal (anorectal) vasoconstrictor

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Active Ingredient (55106-9)

Active ingredients

Calamine 10.5%

Petrolatum 79.25%

Phenylephrine hydrochloride 0.25%

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

symptoms do not improve within 7 days

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are 

presently taking a prescription drug for high blood pressure or depression

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

FARGELIN HEMORRHOIDAL OINTMENT

NDC 55614-610-01

0.705 oz (20 g)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Hemorrhoidal (anorectal) astringent/protectant

Hemorrhoidal (anorectal) protectant

Hemorrhoidal (anorectal) vasoconstrictor

Advanced Ingredient Data

[{"name": "AMBER", "unii": "70J9Z0J26P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALLICARPA NUDIFLORA LEAF", "unii": "IRA5LS3VXW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORYDALIS YANHUSUO TUBER", "unii": "0TUP42692Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANAX NOTOGINSENG ROOT", "unii": "GQX1C1175U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEARL (HYRIOPSIS CUMINGII)", "unii": "A75L5FZ40U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SANGUISORBA OFFICINALIS ROOT", "unii": "4NYV2HT01X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SCUTELLARIA BAICALENSIS ROOT", "unii": "7J95K7ID2S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STYPHNOLOBIUM JAPONICUM FLOWER", "unii": "644C3CSB6E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "10.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "79.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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.", "34071-1": "Warnings For rectal use only", "44425-7": "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", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition worsens symptoms do not improve within 7 days", "50567-7": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are  presently taking a prescription drug for high blood pressure or depression", "50569-3": "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", "51727-6": "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.", "51945-4": "FARGELIN HEMORRHOIDAL OINTMENT NDC 55614-610-01 0.705 oz (20 g)", "53413-1": "Questions or comments? (888) 221-3496 M-F 9 am to 5 pm", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Hemorrhoidal (anorectal) astringent/protectant Hemorrhoidal (anorectal) protectant Hemorrhoidal (anorectal) vasoconstrictor", "55106-9": "Active ingredients Calamine 10.5% Petrolatum 79.25% Phenylephrine hydrochloride 0.25%"}