VITALE SENSITIVE SCALP DAILY SCALP HEALER- pyrithione zinc cream 
New Life Products, Inc.

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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Drug Facts

Active Ingredient

Pyrithione Zinc 0.25%

Purpose

Anti-Dandruff

Use

Controls the symptoms of dandruff

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask adoctor if condition worsens or dowes not improve after regular use of this product as directed.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

For best results apply to affected areas one to four times daily or as directed by a doctor. Spread a small amount in the palms of your hands and apply evenly to the scalp and entire head of hair. Style as desired.

Inactive ingredients

Water (Aqua), Glycerin, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Lanolin, Acetamide MEA, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Beeswax, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Menthol, Camphor, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice, Dimethicone, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Stearalkonium Chloride, Polyquaternium-11, Biotin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Citrus Medica Limonum, (Lemon) Peel Extract, Sodium Borate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, (Parfum)

AFAM CONCEPT, INC.
Chicago, IL 60629

London NW 10 6JH
UK

(800) 262-2326
(773) 838-1336

Registered # 1,387,930

Packaging

IMAGE

IMAGE

VITALE SENSITIVE SCALP DAILY SCALP HEALER 
pyrithione zinc cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC250 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN (UNII: 7EV65EAW6H)  
ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
WHEAT GERM OIL (UNII: 14C97E680P)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
JOJOBA OIL (UNII: 724GKU717M)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
BIOTIN (UNII: 6SO6U10H04)  
ROSEMARY (UNII: IJ67X351P9)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
HOPS (UNII: 01G73H6H83)  
LEMON PEEL (UNII: 72O054U628)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49681-001-01114 g in 1 JAR; Type 0: Not a Combination Product11/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/01/2009
Labeler - New Life Products, Inc. (117815140)
Registrant - New Life Products, Inc. (117815140)
Establishment
NameAddressID/FEIBusiness Operations
New Life Products, Inc.117815140manufacture(49681-001)

Revised: 1/2021
Document Id: a09678e5-709e-4af9-a4e2-b4c2c00f2621
Set id: 9aeada50-2cb2-d113-126a-ddcf05f817b6
Version: 2
Effective Time: 20210121
 
New Life Products, Inc.