LIFECELL Mens

Manufacturer: AmWiner & Raphe Holdings LLC
Effective date: 2022-11-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:51:20

Label at a glance#

ProductLIFECELL Mens

Active ingredientPYRITHIONE ZINC

Label structure9 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 0.1%

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

Other information

SPL UNCLASSIFIED SECTION

• Store at 59° to 77°F (15° to 25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin, Saw Palmetto, Finasteride.

Questions or Comments

SPL UNCLASSIFIED SECTION

Support@lifecellskin.com

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
928d249c-35c3-4d88-a9ef-cf2f2e31b96f	Product name	1	20220706
d00474ae-23eb-a8eb-bf56-520e590cc6db	Product name	2	20170406
0f90664c-9d0e-f046-dc6a-73563cd8347e	Product name	2	20170405

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82627-004-01	2024-01-30	C162847	48780-1	1030e365-38b8-111a-e063-dadaa90a10e2	a9a4f872-3642-4dc5-9728-975117ebb3af

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82627-004-01	LIFECELL Mens	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
82627-004	LIFECELL MENS (PYRITHIONE ZINC) LIQUID [AMWINER & RAPHE HOLDINGS LLC]	1	Legacy NDC, 1 package rows	20221103_a9a4f872-3642-4dc5-9728-975117ebb3af.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

LIFECELL Mens
PYRITHIONE ZINC
WATER
PROPYLENE GLYCOL
PANTHENOL
MINOXIDIL
GREEN TEA LEAF
BIOTIN
FINASTERIDE
SAW PALMETTO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82627-004	82627-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
FINASTERIDE	57GNO57U7G	IACT
SAW PALMETTO	J7WWH9M8QS	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
ec835b93-cb8f-79b6-e053-2995a90a11a4			a9a4f872-3642-4dc5-9728-975117ebb3af	2022-11-02	Warnings	Exact identifier spl id: ec835b93-cb8f-79b6-e053-2995a90a11a4 spl set id: a9a4f872-3642-4dc5-9728-975117ebb3af

Reported adverse events (FAERS/openFDA)#

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