FDA.reportPublic FDA data

Hair Scalp

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:10

Label at a glance#

ProductHair Scalp
Active ingredientApis Mellifera, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Solanum Dulcamara Top, Graphite, Calcium Sulfide, Goldenseal, Hydrofluoric Acid, Potassium Carbonate, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Nerium Oleander Leaf, Kerosene, Phosphoric Acid, Phosphorus, Toxicodendron Pubescens Leaf, Selenium, Sepia Officinalis Juice, Silicon Dioxide, Sulfur, Thuja Occidentalis Leafy Twig
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Hair - Scalp   Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Apis mel. 15x, Arsenicum alb. 15x, Calc.carb. 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Hydrofluoricum acidum 15x, Kali carb. 15x, Lycopodium 15x, Mezereum 15x, Oleander 15x, Petroleum 15x, Phosphoricum ac. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Selenium 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Hydrastis 3x,Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2292-02020-01-31C16284748780-19d75b9d0-bf4a-f424-e053-dadaa90a57ceHair - Scalp
55714-2292-12020-01-31C16284748780-19d75b9d0-bf4a-f424-e053-dadaa90a57ceHair - Scalp
55714-2292-22020-01-31C16284748780-19d75b9d0-bf4a-f424-e053-dadaa90a57ceHair - Scalp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2292-0Hair Scalp.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-2292-1Hair Scalp29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2292-2Hair Scalp59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2292HAIR SCALP (APIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, HYDRASTIS,THUJA OCC.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20121120_07fb9475-dd75-5425-d2bb-06a0b6344b71.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ1
KeroseneACTIVE INGREDIENT1C89KKC04E1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Nerium Oleander LeafACTIVE INGREDIENT7KV510R6H61
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I1
Phosphoric AcidACTIVE INGREDIENTE4GA8884NN1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
SeleniumACTIVE INGREDIENTH6241UJ22B1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N1
SulfurACTIVE INGREDIENT70FD1KFU701
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93971
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
GoldensealACTIVE MOIETYZW3Z11D0JV1
GraphiteACTIVE MOIETY4QQN74LH4O1
Hydrofluoric AcidACTIVE MOIETYRGL5YE86CZ1
KeroseneACTIVE MOIETY1C89KKC04E1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Nerium Oleander LeafACTIVE MOIETY7KV510R6H61
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I1
Phosphoric AcidACTIVE MOIETYE4GA8884NN1
PhosphorusACTIVE MOIETY27YLU75U4W1
SeleniumACTIVE MOIETYH6241UJ22B1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N1
SulfurACTIVE MOIETY70FD1KFU701
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93971
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-229255714-2292-1, 55714-2292-2, 55714-2292-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Apis Mellifera7S82P3R43ZACTIB
Arsenic TrioxideS7V92P67HOACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Calcium Sulfide1MBW07J51QACTIB
GoldensealZW3Z11D0JVACTIB
Hydrofluoric AcidRGL5YE86CZACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Nerium Oleander Leaf7KV510R6H6ACTIB
Kerosene1C89KKC04EACTIB
Phosphoric AcidE4GA8884NNACTIB
Phosphorus27YLU75U4WACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
SeleniumH6241UJ22BACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Sulfur70FD1KFU70ACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 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
1d06d506-7345-4abf-c075-0244a73742b207fb9475-dd75-5425-d2bb-06a0b6344b712011-03-01WarningsExact identifier
spl id: 1d06d506-7345-4abf-c075-0244a73742b2
spl set id: 07fb9475-dd75-5425-d2bb-06a0b6344b71

Reported adverse events (FAERS/openFDA)#

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