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 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Hemorrhoid Cream

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

package label

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride10 [hp_X]  in 1 g
Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root10 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom10 [hp_X]  in 1 g
Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion10 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
Krameria Lappacea Root (UNII: P29ZH1A35Z) (Krameria Lappacea Root - UNII:P29ZH1A35Z) Krameria Lappacea Root10 [hp_X]  in 1 g
Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom10 [hp_X]  in 1 g
Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut3 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top3 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [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 Bark3 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum3 [hp_X]  in 1 g
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 g
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2002-450 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/2013
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2002)

Revised: 8/2013
Document Id: 2516f3a1-9f13-a31e-5ad0-bd5f4664a7b4
Set id: 24893789-7ffc-f1fb-b0b3-50cce43e4d2a
Version: 1
Effective Time: 20130801
 
Newton Laboratories, Inc.