Label: VITALE SENSITIVE SCALP DAILY SCALP HEALER- pyrithione zinc cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49681-001-01 - Packager: New Life Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 21, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
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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.
- Directions:
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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)
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
VITALE SENSITIVE SCALP DAILY SCALP HEALER
pyrithione zinc creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49681-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 250 mg in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white (Off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49681-001-01 114 g in 1 JAR; Type 0: Not a Combination Product 11/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 11/01/2009 Labeler - New Life Products, Inc. (117815140) Registrant - New Life Products, Inc. (117815140) Establishment Name Address ID/FEI Business Operations New Life Products, Inc. 117815140 manufacture(49681-001)
