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

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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Anthracinum 200C, Antimonium Crudum 30C, Hydrocotyle Asiatica 30C, Juglans Regia 6X, Kali Bromatum 30C, Ledum Palustre 6X, Natrum Sulphuratum 200C, Pyrogenium 30C, Radium Bromatum 200C, Sanguinaria Canadensis 3X, Sulphur Iodatum 200C, Thuja Occidentalis 200C, Uritica 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# 69607-0001-1

BIOVEA

HOMEOPATHICS

Acne

Homeopathic

1 FL. OZ. (30ml)

SKIN CARE

ACNE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69607-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 SULFIDE NONAHYDRATE (UNII: C02T02993U) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFIDE NONAHYDRATE	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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69607-0001-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/07/2015	03/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/07/2015	03/31/2022

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(69607-0001) , api manufacture(69607-0001) , label(69607-0001) , pack(69607-0001)

Revised: 3/2022

Document Id: 040e8c01-1cd6-4241-8e03-59ef13ef8e04

Set id: 1946dbcf-4b6d-44f8-ad9e-466226886d26

Version: 2

Effective Time: 20220309

Biovea