Nupercainal ® Bio-Active™ Hemorrhoidal Cream

Manufacturer: Ducere Pharma
Effective date: 2014-04-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:39

Label at a glance#

ProductNupercainal Bio-Active Hemorrhoidal

Active ingredientHamamelis Virginiana Root Bark/Stem Bark, Echinacea purpurea, Centella asiatica, Sambucus Nigra Flowering Top

Label structure11 sections

Dosage and administration

adults and children 12 years and over: if possible, clean 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 applying apply externally to the affected area up to 6 times daily children under 12 years of age: ask a doctor

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-790-6417

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hamamelis virginiana 2x
Proprietary herbal blend 2x:

Echinacea purpurea
Centella asiatica
Sambucus nigra

Purpose

OTC - PURPOSE SECTION

relief of external hemorrhoids

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain, itching and burning due to hemorrhoids and other anorectal disorders

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in or near the eyes
in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

do not use more than directed unless directed by a doctor
do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

bleeding occurs
condition worsens or does not improve within 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: if possible, clean 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 applying
apply externally to the affected area up to 6 times daily
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, PEG-40 hydrogenated castrol oil, propylene glycol, beeswax, paraffin, lanolin, olive oil, titanium dioxide, phenoxy ethanol, menthol, aloe vera, dmdm hydantoin

Questions?

OTC - QUESTIONS SECTION

call 1-800-790-6417 Monday thru Friday 8am-5pm EST

SPL UNCLASSIFIED SECTION

Distributed by:
Ducere Pharma • Somerville, NJ 08876 USA

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Herbal Formula

NDC 55741-412-02

NUPERCAINAL^®
Bio-Active™
HEMORRHOIDAL CREAM

Relieves Pain, Itching & Burning of External Hemorrhoids

✓ Fast Acting Relief ✓ Soothing Herbal Cream

HOMEOPATHIC

NET WT 2 oz (56.7g)

Principal Display Panel - 56.7 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55741-412-02	2020-01-31	C162847	48780-1	9d75b9d0-4f69-f424-e053-dadaa90a57ce	Nupercainal ® Bio-Active™ Hemorrhoidal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55741-412-02	Nupercainal Bio-Active Hemorrhoidal	1 in 1 CARTON	CREAM	1		1
55741-412-02	Nupercainal Bio-Active Hemorrhoidal	56.7 g in 1 TUBE	CREAM	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55741-412	NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]	1	Legacy NDC, 2 package rows	20140424_c0c0bcde-0078-44b7-b207-03ef8547465e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Centella asiatica	ACTIVE INGREDIENT	7M867G6T1U	1
Echinacea purpurea	ACTIVE INGREDIENT	QI7G114Y98	1
Hamamelis Virginiana Root Bark/Stem Bark	ACTIVE INGREDIENT	T7S323PKJS	1
Sambucus Nigra Flowering Top	ACTIVE INGREDIENT	CT03BSA18U	1
Centella asiatica	ACTIVE MOIETY	7M867G6T1U	1
Echinacea purpurea	ACTIVE MOIETY	QI7G114Y98	1
Hamamelis virginiana root bark/stem bark	ACTIVE MOIETY	T7S323PKJS	1
Sambucus nigra flowering top	ACTIVE MOIETY	CT03BSA18U	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
dmdm hydantoin	INACTIVE INGREDIENT	BYR0546TOW	1
lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
olive oil	INACTIVE INGREDIENT	6UYK2W1W1E	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Polyoxyl 40 Hydrogenated Castor Oil	INACTIVE INGREDIENT	7YC686GQ8F	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Nupercainal Bio-Active Hemorrhoidal
Hamamelis Virginiana Root Bark/Stem Bark, Echinacea purpurea, Centella asiatica, and Sambucus Nigra Flowering Top
Hamamelis Virginiana Root Bark/Stem Bark
Echinacea purpurea
Centella asiatica
Sambucus Nigra Flowering Top
petrolatum
Polyoxyl 40 Hydrogenated Castor Oil
propylene glycol
yellow wax
paraffin
lanolin
olive oil
titanium dioxide
phenoxyethanol
menthol
aloe vera leaf
dmdm hydantoin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55741-412	55741-412-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Hamamelis Virginiana Root Bark/Stem Bark	T7S323PKJS	ACTIB
Echinacea purpurea	QI7G114Y98	ACTIB
Centella asiatica	7M867G6T1U	ACTIB
Sambucus Nigra Flowering Top	CT03BSA18U	ACTIB
petrolatum	4T6H12BN9U	IACT
Polyoxyl 40 Hydrogenated Castor Oil	7YC686GQ8F	IACT
propylene glycol	6DC9Q167V3	IACT
yellow wax	2ZA36H0S2V	IACT
paraffin	I9O0E3H2ZE	IACT
lanolin	7EV65EAW6H	IACT
olive oil	6UYK2W1W1E	IACT
titanium dioxide	15FIX9V2JP	IACT
phenoxyethanol	HIE492ZZ3T	IACT
menthol	L7T10EIP3A	IACT
aloe vera leaf	ZY81Z83H0X	IACT
dmdm hydantoin	BYR0546TOW	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 213 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Polyoxyl 40 Hydrogenated Castor Oil	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	CAPSULE, COATED / ORAL	101.25 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
yellow wax	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
olive oil	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Polyoxyl 40 Hydrogenated Castor Oil	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
dmdm hydantoin	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii candidate
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b8b95bde-20f8-4c08-aac9-dc4a8130d673			c0c0bcde-0078-44b7-b207-03ef8547465e	2014-04-18	Warnings	Exact identifier spl id: b8b95bde-20f8-4c08-aac9-dc4a8130d673 spl set id: c0c0bcde-0078-44b7-b207-03ef8547465e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.