ACNE- anthracinum, antimonium crudum, hydrocotyle asiatica, juglans regia, kali bromatum, ledum palustre, natrum sulphuricum, pyrogenium, radium bromatum, sanguinaria canadensis, sulphur iodatum, thuja occidentalis, urtica urens spray

Acne by

Drug Labeling and Warnings

Acne by is a Homeopathic medication manufactured, distributed, or labeled by Biovea, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Anthracinum 200C, Antimonium Crudum 30C, Hydrocotyle Asiatica 30C, Juglans Regia 6X, Kali Bromatum 30C, Ledum Palustre 6X, Natrum Sulphuricum 200C, Pyrogenium 30C, Radium Bromatum 200C, Sanguinaria Canadensis 3X, Sulphur Iodatum 200C, Thuja Occidentalis 200C, Urtica Urens 3X.

INDICATIONS:

Advanced homeopathic oral spray for the temporary relief of pimples, blemishes, redness and inflammation associated with acne.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If symptoms persist, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults & children over 12. Spray twice under the tongue 3 times per day.

Children 12 & under. Consult a doctor prior to use.

INDICATIONS:

Advanced homeopathic oral spray for the temporary relief of pimples, blemishes, redness and inflammation associated with acne.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, purified water.

QUESTIONS:

Distributed by: BIOVEA

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

NDC# 69607-0012-1

BIOVEA

HOMEOPATHICS

Acne

Homeopathic

1 FL. OZ. (30ml)

SKIN CARE

INGREDIENTS AND APPEARANCE

ACNE 
anthracinum, antimonium crudum, hydrocotyle asiatica, juglans regia, kali bromatum, ledum palustre, natrum sulphuricum, pyrogenium, radium bromatum, sanguinaria canadensis, sulphur iodatum, thuja occidentalis, urtica urens spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N)	BACILLUS ANTHRACIS IMMUNOSERUM RABBIT	200 [hp_C]  in 1 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	30 [hp_C]  in 1 mL
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	30 [hp_C]  in 1 mL
JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K)	JUGLANS REGIA FRUIT RIND, IMMATURE	6 [hp_X]  in 1 mL
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105)	JUGLANS REGIA LEAF	6 [hp_X]  in 1 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	30 [hp_C]  in 1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	200 [hp_C]  in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	30 [hp_C]  in 1 mL
RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T)	RADIUM BROMIDE	200 [hp_C]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_X]  in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	200 [hp_C]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	200 [hp_C]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69607-0012-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/13/2015

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69607-0012) , api manufacture(69607-0012) , label(69607-0012) , pack(69607-0012)