LIFECELL WOMENS- pyrithione zinc liquid 
AmWiner & Raphe Holdings LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Pyrithione Zinc

Purpose

Seborrheic dermatitis

Uses

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

Warnings

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

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

Other information

• Store at 59° to 77°F (15° to 25°C)

Inactive ingredients

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

Questions or Comments

Support@lifecellskin.com

Product label

image description

LIFECELL WOMENS 
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82627-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
MINOXIDIL (UNII: 5965120SH1)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BIOTIN (UNII: 6SO6U10H04)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82627-003-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/01/2022
Labeler - AmWiner & Raphe Holdings LLC (113433590)
Establishment
NameAddressID/FEIBusiness Operations
AmWiner & Raphe Holdings LLC113433590manufacture(82627-003)

Revised: 11/2022
Document Id: ec835925-e8f2-19ec-e053-2a95a90a8945
Set id: 9a9b1fa8-7681-4d4a-8c46-4f3488dd614d
Version: 1
Effective Time: 20221102
 
AmWiner & Raphe Holdings LLC