ACNE TONIC- anthracinum, antimonium crud, apis mel, carbo an, hamamelis, hepar suis, hydrocotyle, kali brom, merc corros, nat sulphuricum, pyrogenium, radium brom, sanguinaria canadensis, sulphur iod, thuja occ, urtica ur liquid

Acne Tonic by

Drug Labeling and Warnings

Acne Tonic by is a Homeopathic medication manufactured, distributed, or labeled by Eight and Company L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Anthracinum 200C, Antimonium crud 30C, Apis mel 4X, Carbo an 12X, Hamamelis 4X, Hepar suis 6X, Hydrocotyle 30C, Kali brom 30C, Mercurius corros 200C, Natrum sulphuricum 200C, Pyrogenium 30C, Radium bromatum 200C, Sanguinaria 4X, Sulphur iod 200C, Thuja occ 200C, Urtica ur 3X

WARNINGS

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Adults and children over 12: 2 sprays into the mouth 3 times per day.
• Under age 12: consult a health care professional.

PURPOSE

Temporarily relieves acne discomfort and the common symptoms of acne, including:

• Face and body breakouts
• redness
• itching and inflammation

OTHER SAFETY INFORMATION

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

INACTIVE INGREDIENT

Inactive Ingredients: Non-GMO Glycerin, organic alcohol 20% v/v and purified water.

INDICATIONS & USAGE

Temporarily relieves acne discomfort and the common symptoms of acne, including:

° face and body breakouts

° redness

° itching and inflammation

° natural

° gluten & lactose free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE TONIC 
anthracinum, antimonium crud, apis mel, carbo an, hamamelis, hepar suis, hydrocotyle, kali brom, merc corros, nat sulphuricum, pyrogenium, radium brom, sanguinaria canadensis, sulphur iod, thuja occ, urtica ur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-1027
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 41 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	30 [hp_C]  in 41 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	4 [hp_X]  in 41 mL
CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433)	CARBO ANIMALIS	12 [hp_X]  in 41 mL
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 41 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X]  in 41 mL
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	30 [hp_C]  in 41 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	30 [hp_C]  in 41 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	200 [hp_C]  in 41 mL
SODIUM SULFIDE NONAHYDRATE (UNII: C02T02993U) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFIDE NONAHYDRATE	200 [hp_C]  in 41 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	30 [hp_C]  in 41 mL
RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T)	RADIUM BROMIDE	200 [hp_C]  in 41 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	4 [hp_X]  in 41 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	200 [hp_C]  in 41 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	200 [hp_C]  in 41 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	4 [hp_X]  in 41 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61096-1027-1	1 in 1 CARTON	03/08/2019
1		41 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		03/08/2019

Labeler - Eight and Company L.L.C (927364120)

Registrant - Eight and Company L.L.C (927364120)