Hemorrhoid Cream

Hemorrhoid Cream
SPL v1
SPL
SPL Set ID 24893789-7ffc-f1fb-b0b3-50cce43e4d2a
Route
TOPICAL
Published
Effective Date 2013-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe (10 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Fluoride Ion Collinsonia Canadensis Root Crotalus Horridus Horridus Venom 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
Inactive Ingredients
Water Olive Oil Cocoa Butter Royal Jelly Jojoba Oil Lecithin, Soybean Glycerin Alcohol Citrus Paradisi Seed Lonicera Japonica Flower Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-08-01

Description

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


Medication Information

Description

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

Package Label

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 Purpose Section

Otc Questions Section

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

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.

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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 Purpose Section (OTC - PURPOSE SECTION)

Otc Questions Section (OTC - QUESTIONS SECTION)

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

Inactive Ingredient 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.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (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 (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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