RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5

Manufacturer: AmWiner & Raphe Holdings LLC
Effective date: 2022-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:50:36

Label at a glance#

ProductRAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Indications and uses

•Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis. • Helps eliminate recurrence of seborrheic dermatitis

Dosage and administration

Apply to affected area one ml two times daily or as directed by the physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc

Purpose

OTC - PURPOSE SECTION

Seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

•Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.
• Helps eliminate recurrence of seborrheic dermatitis

Warnings

WARNINGS SECTION

For external use only
Ask a doctor before use if condition covers a large area.
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area one ml two times daily or as directed by the physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin

Other information

SPL UNCLASSIFIED SECTION

• Store at 59° to 77°F (15° to 25°C)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245090	zinc pyrithione 0.1 % Topical Solution	PSN	1
1245090	zinc pyrithione 1 MG/ML Topical Solution	SCD	1
1245090	zinc pyrithione 0.1 % Topical Solution	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82627-001-01	2024-01-30	C162847	48780-1	1030e365-4d1a-111a-e063-dadaa90a10e2	b9b5ab01-81c2-4832-9bd8-9001258cfc2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82627-001-01	RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5	60 mL in 1 BOTTLE	LIQUID	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82627-001	RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5 (PYRITHIONE ZINC) LIQUID [AMWINER & RAPHE HOLDINGS LLC]	1	Legacy NDC, 1 package rows	20220904_b9b5ab01-81c2-4832-9bd8-9001258cfc2a.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5
PYRITHIONE ZINC
WATER
PROPYLENE GLYCOL
PANTHENOL
MINOXIDIL
GREEN TEA LEAF
BIOTIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82627-001	82627-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PANTHENOL	WV9CM0O67Z	IACT
MINOXIDIL	5965120SH1	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
BIOTIN	6SO6U10H04	IACT
PYRITHIONE ZINC	R953O2RHZ5	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e7a495fb-af44-6b84-e053-2a95a90aab41			b9b5ab01-81c2-4832-9bd8-9001258cfc2a	2022-09-01	Warnings	Exact identifier spl id: e7a495fb-af44-6b84-e053-2a95a90aab41 spl set id: b9b5ab01-81c2-4832-9bd8-9001258cfc2a

Reported adverse events (FAERS/openFDA)#

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