Mielle Rosemary Mintscalp Hair Strengthening Oil

Manufacturer
Guangzhou Hanhai Trading Co., Ltd
Effective date
2024-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:17

Label at a glance#

ProductMielle Rosemary Mintscalp Hair Strengthening Oil
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area. using more or more often will not improve resultsApply a small amount of oil to scalp, massage oil in ith fingers and comb through to ends of hair. Leave n and style as desired.Daily Use: Apply a small amunt to scalp and comb through to ends, Split End Cre: Apply oil to ends of hair, place a processing cap (n head and leave on f...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Encourage hair growth

Use

INDICATIONS & USAGE SECTION

Help you solve hair problems. From nourishing hair follicles, smoothing split ends, to helping dry the scalp, this hair oil uses natural organic ingredients and essential oils to provide the necessary care for your hair. Use it for protective styles, including braids and braids, and enjoy its fresh and vibrant fragrance during the next hot oil treatment.

Warnings

WARNINGS SECTION

For external use only
keep away from fire and fame
Do not use near eyes.
Keep out of reach of children.

Do not use

OTC - DO NOT USE SECTION

• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• you do not know the reason for your hair loss
• you are under 18 years of age. Do not use on babies and children
• your scalp is red, inflamed, infected, irritated or painful
• you use other medicines on the scalp

When Using

OTC - WHEN USING SECTION

it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

Stop Use

OTC - STOP USE SECTION

• chest pain, rapid heartbeat, faintness, or dizziness occurs
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs

Ask Doctor

OTC - ASK DOCTOR SECTION

When Pregnant or breast-feeding

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
using more or more often will not improve resultsApply a small amount of oil to scalp, massage oil in ith fingers and comb through to ends of hair. Leave n and style as desired.Daily Use: Apply a small amunt to scalp and comb through to ends, Split End Cre: Apply oil to ends of hair, place a processing cap (n head and leave on for 10 minutes. Rinse and proced with shampooing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycine Soja (Soybean) Oil, Ricinus Communis (Castpr)Seed Oil,Rosmarinus Ofhcinalis (Rosemary)Leaf Oil,Simmondsia Chinensis (Jojoba) Seed Oil, Mentha Piperita (Peppermint) Oil, Eucalvptus Globolus (Euc alyptus)Leaf Oil, Menthol, Melalueca Alternifolia(Te a Tree)Leaf Oil,Cocos Nucifera (Coconut) Oil,Equise tum Arvense(Horsetail)Extract,Aloe Barbadensis Ext ract,Lavandula Angustifolia (Lavender) Oil, Triticum Vulgare (Wheat)Germ Oil, Carthamus Tinctorius (Safflower) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Vitis Vinifera (Grape) Seed

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83675-034-012025-07-29C16284748780-13b156c62-345c-fb37-e063-e6dba90a4e0783675-034

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83675-034-01Mielle Rosemary Mintscalp Hair Strengthening Oil59 mL in 1 BOTTLEOIL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83675-034MIELLE ROSEMARY MINTSCALP HAIR STRENGTHENING OIL (ROSEMARY MINTSCALP HAIR STRENGTHENING OIL) OIL [GUANGZHOU HANHAI TRADING CO., LTD]11 package rows20240206_1090b061-26ab-262e-e063-6394a90a27d4.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83675-03483675-034-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
1090b061-26ac-262e-e063-6394a90a27d41090b061-26ab-262e-e063-6394a90a27d42024-02-04WarningsExact identifier
spl id: 1090b061-26ac-262e-e063-6394a90a27d4
spl set id: 1090b061-26ab-262e-e063-6394a90a27d4

Reported adverse events (FAERS/openFDA)#

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