Search by Drug Name or NDC

NDC 62795-1013-02 BHI Acne 8; 4; 5; 10; 2; 12; 6; 6; 12; 8; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

BHI Acne 8; 4; 5; 10; 2; 12; 6; 6; 12; 8; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

BHI Acne is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by MediNatura. The primary component is ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA PURPUREA; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; SILVER NITRATE; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRO.

Product Information

NDC	62795-1013
Product ID	62795-1013_0fc9b5ab-6737-4997-b4a1-5d51755b5c22
Associated GPIs	99870010000300
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BHI Acne
Proprietary Name Suffix	n/a
Non-Proprietary Name	SILVER NITRATE, ARNICA MONTANA, 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 OCC
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	8; 4; 5; 10; 2; 12; 6; 6; 12; 8; 6; 6; 6
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA PURPUREA; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; SILVER NITRATE; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRO
Labeler Name	MediNatura
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 62795-1013-02 (62795101302)

Pricing Information	N/A
NDC Package Code	62795-1013-2
Billing NDC	62795101302
Package	100 TABLET in 1 BOTTLE (62795-1013-2)
Marketing Start Date	2014-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 850b5d4f-4833-48e5-89bc-752c96c5b947 Details

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

USES

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

WARNINGS

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

Tamper Evident: Use this product only if imprinted shrink seal around neck and cap is intact.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

DIRECTIONS

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, consult your health professional.

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

USES

Acne Relief Tablets

Relieves:

• Redness

• Pain

• Tenderness

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BHI ACNE

silver nitrate, arnica montana, 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	Item Code (Source)	NDC:62795-1013
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	8 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	8 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	5 [hp_X]
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	6 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	2 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	10 [hp_X]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	12 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Leafman
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62795-1013-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2014	09/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/30/2014	09/30/2025

Labeler - MediNatura (079324099)

Name	Address	ID/FEI	Business Operations
Establishment
MediNatura		102783016	manufacture(62795-1013)

Revised: 10/2021

Document Id: 0fc9b5ab-6737-4997-b4a1-5d51755b5c22

Set id: 850b5d4f-4833-48e5-89bc-752c96c5b947

Version: 3

Effective Time: 20211018

Search by Drug Name or NDC

NDC 62795-1013-02 BHI Acne 8; 4; 5; 10; 2; 12; 6; 6; 12; 8; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

BHI Acne 8; 4; 5; 10; 2; 12; 6; 6; 12; 8; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 62795-1013-02 (62795101302)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 850b5d4f-4833-48e5-89bc-752c96c5b947 Details

ACTIVE INGREDIENTS

INACTIVE INGREDIENTS

USES

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

USES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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