FDA.reportPublic FDA data

Hair-Scalp

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:38

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

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hydrastis 6x, Thuja occ. 6x, 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.

OTC - PURPOSE SECTION

Formulated for associated symptoms 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 alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If p regnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2448-1Hair-Scalp30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2448HAIR-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, THUJA OCC.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201201_9ab3b944-443c-74a1-e053-2a95a90aa0e5.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-244855714-2448-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
GOLDENSEALZW3Z11D0JVACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
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
WATER059QF0KO0RIACT

Source Document#

Source XML

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
Hair-ScalpAPIS 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, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
ndc (package): 55714-2448-1
ndc (product): 55714-2448
ndc11 (package): 55714244801
spl id: b556909e-c4c8-0dd2-e053-2a95a90add40
spl set id: 9ab3b944-443c-74a1-e053-2a95a90aa0e5

Reported adverse events (FAERS/openFDA)#

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