FDA.reportPublic FDA data

Hemorrhoid Cream

Manufacturer
Newton Laboratories, Inc.
Effective date
2013-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:20

Label at a glance#

ProductHemorrhoid Cream
Active ingredientAloe, Arsenic Trioxide, Calcium Fluoride, Collinsonia Canadensis Root, Crotalus Horridus Horridus Venom, Hydrofluoric Acid, Lachesis Muta Venom, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Krameria Lappacea Root, Vipera Berus Venom, Horse Chestnut, Calendula Officinalis Flowering Top, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Solidago Virgaurea Flowering Top, Urtica Urens
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Hemorrhoid Cream: Formulated for symptoms associated with hemorrhoids such as itching, inflammation, engorgement and stinging, burning pain.

DOSAGE & ADMINISTRATION SECTION

Directions: EXTERNAL USE ONLY. Ages 2 and up, apply a thin coating up to four times daily to affected area. Repeat as needed or as directed by your healthcare professional. Under age 2, consult a licensed healthcare professional. Avoid eye contact; if eye contact occurs, rinse with water for at least 15 minutes. If allergic response or irritation occurs or persists, discontinue use and consult a licensed healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Aloe 10x, Arsenicum alb. 10x, Calc. fluor. 10x, Collinsonia 10x, Crotalus horridus 10x, Hydrofluoricum acidum 10x, Lachesis 10x, Lycopodium 10x, Nux vom. 10x, Ratanhia 10x, Vipera berus 10x, Aesculus hipp. 3x, Calendula 3x, Echinacea 3x, Hamamelis 3x, Hypericum 3x, Solidago 3x, Urtica ur. 3x.

INACTIVE INGREDIENT SECTION

USP Purified Water, Pomace Olive Oil, El Deodorized Cocoa Butter, Beeswax (organic), Jojoba Esters, Soy Lecithin (organic), USP Glycerin, natural (organic, vegetable), USP Gluten-free, non-GMO, Cane Alcohol (organic), Grapefruit Seed Extract, Plant preservatives (natural), Gluten-free, non-GMO, Xanthan Gum.

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2002-42020-01-31C16284748780-19d75b9d0-fa5d-f424-e053-dadaa90a57ceHemorrhoid Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2002-4Hemorrhoid Cream50 g in 1 BOTTLE, PUMPCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2002HEMORRHOID CREAM (ALOE, ARSENICUM ALB., CALC. FLUOR., COLLINSONIA, CROTALUS HORRIDUS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NUX VOM., RATANHIA, VIPERA BERUS, AESCULUS HIPP., CALENDULA, ECHINACEA, HAMAMELIS, HYPERICUM, SOLIDAGO, URTICA UR.) CREAM [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20131227_24893789-7ffc-f1fb-b0b3-50cce43e4d2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AloeACTIVE INGREDIENTV5VD430YW91
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Calcium FluorideACTIVE INGREDIENTO3B55K4YKI1
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ1
Collinsonia Canadensis RootACTIVE INGREDIENTO2630F3XDR1
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
Horse ChestnutACTIVE INGREDIENT3C18L6RJAZ1
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Krameria Lappacea RootACTIVE INGREDIENTP29ZH1A35Z1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF91
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M1
AloeACTIVE MOIETYV5VD430YW91
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ1
Collinsonia Canadensis RootACTIVE MOIETYO2630F3XDR1
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Fluoride IonACTIVE MOIETYQ80VPU408O1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
Horse ChestnutACTIVE MOIETY3C18L6RJAZ1
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Krameria Lappacea RootACTIVE MOIETYP29ZH1A35Z1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Urtica UrensACTIVE MOIETYIHN2NQ5OF91
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M1
AlcoholINACTIVE INGREDIENT3K9958V90M1
Citrus Paradisi SeedINACTIVE INGREDIENT12F08874Y71
Cocoa ButterINACTIVE INGREDIENT512OYT1CRR1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Jojoba OilINACTIVE INGREDIENT724GKU717M1
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM621
Lonicera Japonica FlowerINACTIVE INGREDIENT4465L2WS4Y1
Olive OilINACTIVE INGREDIENT6UYK2W1W1E1
Royal JellyINACTIVE INGREDIENTL497I37F0C1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-200255714-2002-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
AloeV5VD430YW9ACTIB
Arsenic TrioxideS7V92P67HOACTIB
Calcium FluorideO3B55K4YKIACTIB
Collinsonia Canadensis RootO2630F3XDRACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Hydrofluoric AcidRGL5YE86CZACTIM
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Krameria Lappacea RootP29ZH1A35ZACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
Horse Chestnut3C18L6RJAZACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Hamamelis Virginiana Root Bark/stem BarkT7S323PKJSACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Water059QF0KO0RIACT
Olive Oil6UYK2W1W1EIACT
Cocoa Butter512OYT1CRRIACT
Royal JellyL497I37F0CIACT
Jojoba Oil724GKU717MIACT
Lecithin, Soybean1DI56QDM62IACT
GlycerinPDC6A3C0OXIACT
Alcohol3K9958V90MIACT
Citrus Paradisi Seed12F08874Y7IACT
Lonicera Japonica Flower4465L2WS4YIACT
Xanthan GumTTV12P4NEEIACT

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 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Olive OilOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2516f3a1-9f13-a31e-5ad0-bd5f4664a7b424893789-7ffc-f1fb-b0b3-50cce43e4d2a2013-08-01WarningsExact identifier
spl id: 2516f3a1-9f13-a31e-5ad0-bd5f4664a7b4
spl set id: 24893789-7ffc-f1fb-b0b3-50cce43e4d2a

Reported adverse events (FAERS/openFDA)#

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