BHI ACNE- silver nitrate, arnica montana root, atropa belladonna, bryonia alba root, solanum dulcamara top, echinacea purpurea, calcium sulfide, lachesis muta venom, phytolacca americana root, pulsatilla vulgaris, rancid beef, toxicodendron pubescens leaf and thuja occidentalis leafy twig tablet
Heel 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.

----------

BHI Acne Tablet

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS AND USAGE

For the temporary relief of minor acne symptoms:

Redness
Pain
Tenderness

WARNINGS

Warning: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist of worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Acne or any of its ingredients exists.

DOSAGE AND ADMINISTRATION

Directions: At first sign of symptoms:

Adults and children 12 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.

Do not exceed 12 tablets in 24 hours.

Standard dosage:

Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

For children under 12 years, consult your healthcare provider.

Allow tablets to dissolve completely in the mouth, do not swallow.

ACTIVE INGREDIENTS

Each tablet contains Argentum nitricum 8X,*Arnica montana, radix 6X, *Belladonna 4X, *Bryonia alba 5X, *Dulcamara 6X, *Echinacea purpurea 2X, Hepar sulphuris calcareum 10X, *Lachesis mutus 12X, *Phytolacca decandra 6X, *Pulsatilla 6X, *Pyrogenium 12X, *Rhus toxicodendron 6X, *Thuja occidentalis 6X 23.1 mg each.

*Natural ingredients

INACTIVE INGREDIENTS

Lactose, Magnesium stearate

PURPOSE

For the temporary relief of minor acne symptoms: redness, pain, tenderness

BHI Acne.jpg

BHI ACNE
silver nitrate, arnica montana root, atropa belladonna, bryonia alba root, solanum dulcamara top, echinacea purpurea, calcium sulfide,lachesis muta venom,phytolacca americana root, pulsatilla vulgaris, rancid beef, toxicodendron pubescens leaf and thuja occidentalis leafy twig tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50114-6926
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILVER NITRATE (SILVER CATION)	SILVER NITRATE	8 [hp_X]
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT)	ARNICA MONTANA ROOT	6 [hp_X]
ATROPA BELLADONNA (ATROPA BELLADONNA)	ATROPA BELLADONNA	4 [hp_X]
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT)	BRYONIA ALBA ROOT	5 [hp_X]
SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP)	SOLANUM DULCAMARA TOP	6 [hp_X]
ECHINACEA PURPUREA (ECHINACEA PURPUREA)	ECHINACEA PURPUREA	2 [hp_X]
CALCIUM SULFIDE (CALCIUM SULFIDE)	CALCIUM SULFIDE	10 [hp_X]
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM)	LACHESIS MUTA VENOM	12 [hp_X]
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT)	PHYTOLACCA AMERICANA ROOT	6 [hp_X]
PULSATILLA VULGARIS (PULSATILLA VULGARIS)	PULSATILLA VULGARIS	6 [hp_X]
RANCID BEEF (RANCID BEEF)	RANCID BEEF	12 [hp_X]
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE
MAGNESIUM STEARATE

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	BHI;O;M
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-6926-2	100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/30/2013	08/20/2014

Labeler - Heel Inc. (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Heel Inc.		102783016	manufacture(50114-6926)

Revised: 8/2014

Document Id: c4b87a4f-50b3-44e7-a870-3658f0cc9d33

Set id: d177617f-9d1c-4d43-b660-2dbc98a28542

Version: 2

Effective Time: 20140819

Heel Inc.