Hemorrhoid Cream description, usages, side effects, indications, overdosage, supplying and lots more!

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Hemorrhoid Cream

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Hemorrhoid Cream


FULL PRESCRIBING INFORMATION: 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.

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

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 label Item Code (Source) NDC:55714-2002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ALOE ALOE 10 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
CALCIUM FLUORIDE Fluoride Ion 10 [hp_X]
COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT 10 [hp_X]
CROTALUS HORRIDUS HORRIDUS VENOM Crotalus Horridus Horridus Venom 10 [hp_X]
Hydrofluoric Acid Hydrofluoric Acid 10 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
KRAMERIA LAPPACEA ROOT KRAMERIA LAPPACEA ROOT 10 [hp_X]
Vipera Berus Venom Vipera Berus Venom 10 [hp_X]
HORSE CHESTNUT HORSE CHESTNUT 3 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]
SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]
Urtica Urens URTICA URENS 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
water
olive oil
COCOA BUTTER
ROYAL JELLY
Jojoba Oil
LECITHIN, SOYBEAN
GLYCERIN
ALCOHOL
CITRUS PARADISI SEED
LONICERA JAPONICA FLOWER
XANTHAN GUM

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-08-01


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