HEMORRHOID 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

Hemorrhoid Cream by

Drug Labeling and Warnings

Hemorrhoid Cream by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

OTC - PURPOSE SECTION

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

INGREDIENTS AND APPEARANCE

HEMORRHOID 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9)	Aloe	10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	10 [hp_X]  in 1 g
Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O)	Calcium Fluoride	10 [hp_X]  in 1 g
Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR)	Collinsonia Canadensis Root	10 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956)	Crotalus Horridus Horridus Venom	10 [hp_X]  in 1 g
Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	10 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	10 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	10 [hp_X]  in 1 g
Krameria Lappacea Root (UNII: P29ZH1A35Z) (Krameria Lappacea Root - UNII:P29ZH1A35Z)	Krameria Lappacea Root	10 [hp_X]  in 1 g
Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M)	Vipera Berus Venom	10 [hp_X]  in 1 g
Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ)	Horse Chestnut	3 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ)	Calendula Officinalis Flowering Top	3 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 g
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS)	Hamamelis Virginiana Root Bark/stem Bark	3 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	3 [hp_X]  in 1 g
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50)	Solidago Virgaurea Flowering Top	3 [hp_X]  in 1 g
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9)	Urtica Urens	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Olive Oil (UNII: 6UYK2W1W1E)
Cocoa Butter (UNII: 512OYT1CRR)
Royal Jelly (UNII: L497I37F0C)
Jojoba Oil (UNII: 724GKU717M)
Lecithin, Soybean (UNII: 1DI56QDM62)
Glycerin (UNII: PDC6A3C0OX)
Alcohol (UNII: 3K9958V90M)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Lonicera Japonica Flower (UNII: 4465L2WS4Y)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2002-4	50 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2013

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2002)