FDA.reportPublic FDA data

Acne Tonic

Manufacturer
Eight and Company L.L.C | King Bio Inc. | Apotheca Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:20

Label at a glance#

ProductAcne Tonic
Active ingredientBACILLUS ANTHRACIS IMMUNOSERUM RABBIT, ANTIMONY TRISULFIDE, APIS MELLIFERA, CARBO ANIMALIS, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PORK LIVER, CENTELLA ASIATICA WHOLE, POTASSIUM BROMIDE, MERCURIC CHLORIDE, SODIUM SULFIDE NONAHYDRATE, RANCID BEEF, RADIUM BROMIDE, SANGUINARIA CANADENSIS ROOT, SULFUR IODIDE, THUJA OCCIDENTALIS LEAFY TWIG, URTICA URENS WHOLE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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

° Face and body breakouts
° redness
° itching and inflammation

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

Children under 12: consult a health care professional.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

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

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61096-1027

sprayology

Acne Tonic

RELIEVES ACNE SYMPTOMS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Acne Tonic LBLAcne Tonic LBL

Acne Tonic CNTAcne Tonic CNT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361096002713GTIN-13: 0361096002713
EAN-13: 0361096002713
GTIN-12: 361096002713
UPC-A: 361096002713
GTIN storage (14 digits): 00361096002713		ETCO0002 Acne Tonic CTN 3-5-19.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-1027-12023-12-13C16284748780-1ba0f9c33-2fac-a910-e053-dadaa90a0b85Acne Tonic
61096-1027-12023-01-30C16284748780-1ba0f9c33-2fac-a910-e053-dadaa90a0b85Acne Tonic
61096-1027-12021-02-15C16284748780-1ba0f9c33-2fac-a910-e053-dadaa90a0b85Acne Tonic
61096-1027-12021-01-29C16284748780-1ba0f9c33-2fac-a910-e053-dadaa90a0b85Acne Tonic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-1027-1Acne Tonic1 in 1 CARTONLIQUID19
61096-1027-1Acne Tonic41 mL in 1 BOTTLE, SPRAYLIQUID419

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38U1
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
BACILLUS ANTHRACIS IMMUNOSERUM RABBITACTIVE INGREDIENT41LZ22DD4N1
CARBO ANIMALISACTIVE INGREDIENT279O8I04331
CENTELLA ASIATICAACTIVE INGREDIENT7M867G6T1U1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R1
PORK LIVERACTIVE INGREDIENT6EC706HI7F1
POTASSIUM BROMIDEACTIVE INGREDIENTOSD78555ZM1
RADIUM BROMIDEACTIVE INGREDIENTR74O7T85691
RANCID BEEFACTIVE INGREDIENT29SUH5R3HU1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SODIUM SULFIDE NONAHYDRATEACTIVE INGREDIENTC02T02993U1
SULFUR IODIDEACTIVE INGREDIENTL6L8KA2AA01
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ANTIMONY TRISULFIDEACTIVE MOIETYF79059A38U1
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
BACILLUS ANTHRACIS IMMUNOSERUM RABBITACTIVE MOIETY41LZ22DD4N1
BROMIDE IONACTIVE MOIETY952902IX061
CARBO ANIMALISACTIVE MOIETY279O8I04331
CENTELLA ASIATICAACTIVE MOIETY7M867G6T1U1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
MERCURIC CATIONACTIVE MOIETYED30FJ8Y421
PORK LIVERACTIVE MOIETY6EC706HI7F1
RADIUM CATIONACTIVE MOIETY05456MVL7T1
RANCID BEEFACTIVE MOIETY29SUH5R3HU1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
SULFUR IODIDEACTIVE MOIETYL6L8KA2AA01
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61096-102761096-1027-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
APIS MELLIFERA7S82P3R43ZACTIB
CARBO ANIMALIS279O8I0433ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
PORK LIVER6EC706HI7FACTIB
CENTELLA ASIATICA WHOLE7M867G6T1UACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
SODIUM SULFIDE NONAHYDRATEC02T02993UACTIB
RANCID BEEF29SUH5R3HUACTIB
RADIUM BROMIDER74O7T8569ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TonicANTHRACINUM, 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 UREight and Company L.L.Cbb635329-47ce-47a5-b18d-124d58a03e792025-12-18WarningsExact identifier
ndc (package): 61096-1027-1
ndc (product): 61096-1027
ndc11 (package): 61096102701
spl id: 2796c451-737e-4bdc-8fff-f0565ff0a16c
spl set id: bb635329-47ce-47a5-b18d-124d58a03e79

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.