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 
Eight and Company L.L.C

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 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.

PURPOSE:

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

° Face and body breakouts
° redness
° itching and inflammation

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. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: 2 sprays into the mouth 3 times per day.

Children under 12: consult a health care professional.

OTHER INFORMATION:

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

INDICATIONS:

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

INACTIVE INGREDIENTS:

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

QUESTIONS:

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

PACKAGE LABEL DISPLAY:

NDC 61096-1027

sprayology

Acne Tonic

RELIEVES ACNE SYMPTOMS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Acne Tonic LBL

Acne Tonic CNT

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-1027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT200 [hp_C]  in 41 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE30 [hp_C]  in 41 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA4 [hp_X]  in 41 mL
CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS12 [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 BARK4 [hp_X]  in 41 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER6 [hp_X]  in 41 mL
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE30 [hp_C]  in 41 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE30 [hp_C]  in 41 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE200 [hp_C]  in 41 mL
SODIUM SULFIDE NONAHYDRATE (UNII: C02T02993U) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFIDE NONAHYDRATE200 [hp_C]  in 41 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_C]  in 41 mL
RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T) RADIUM BROMIDE200 [hp_C]  in 41 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 41 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE200 [hp_C]  in 41 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]  in 41 mL
URTICA URENS WHOLE (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS WHOLE4 [hp_X]  in 41 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61096-1027-11 in 1 CARTON03/08/2019
141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/08/2019
Labeler - Eight and Company L.L.C (927364120)
Registrant - Apotheca Company (844330915)

Revised: 12/2023
Document Id: b9b592f2-7467-46c8-989f-c61e4a599375
Set id: bb635329-47ce-47a5-b18d-124d58a03e79
Version: 4
Effective Time: 20231213
 
Eight and Company L.L.C