HEMORRHOID GEL- achillea millefolium, aesculus hippocastanum, hamamelis virginiana, ruscus aculeatus, aloe socotrina, paeonia officinalis, ignatia amara, nitricum acidum, nux vomica, phosphorus, podophyllum peitatum, pulsatilla, ratanhia, chelidonium majus, sulphur gel

Hemorrhoid Gel by

Drug Labeling and Warnings

Hemorrhoid Gel by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C

INDICATIONS & USAGE

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

PURPOSE

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

DOSAGE & ADMINISTRATION

DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS

WARNINGS:

• FOR TOPICAL USE ONLY.
• Consult a physician for use in children under 12 years of age.
• IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
• KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
• Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Carbomer 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

QUESTIONS

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL

NDC: 43406-0709-5

Hemorrhoid Gel

HOMEOPATHIC

 2 oz (56.7g)

INGREDIENTS AND APPEARANCE

HEMORRHOID GEL 
achillea millefolium, aesculus hippocastanum, hamamelis virginiana, ruscus aculeatus, aloe socotrina, paeonia officinalis, ignatia amara, nitricum acidum, nux vomica, phosphorus, podophyllum peitatum, pulsatilla, ratanhia, chelidonium majus, sulphur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43406-0709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM WHOLE	4 [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	4 [hp_X]  in 1 g
RUSCUS ACULEATUS WHOLE (UNII: 5KEZ82GMGU) (RUSCUS ACULEATUS WHOLE - UNII:5KEZ82GMGU)	RUSCUS ACULEATUS WHOLE	4 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	6 [hp_X]  in 1 g
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	6 [hp_X]  in 1 g
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]  in 1 g
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 g
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	12 [hp_X]  in 1 g
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	12 [hp_X]  in 1 g
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z)	KRAMERIA LAPPACEA ROOT	30 [hp_C]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	30 [hp_C]  in 1 g
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	30 [hp_C]  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43406-0709-5	56.7 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	09/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/12/2019

Labeler - Natural Creations, Inc (018022074)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc		030572478	manufacture(43406-0709)