Label: WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE ANTI-DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 0363-4138-01
- Packager: Walgreen Company
- 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 April 7, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
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Inactive ingredients
water, ammonium lauryl sulfate, glycerin, ammonium laureth sulfate, cocamide MEA, glycol distearate, cetyl alcohol, fragrance, aloe barbadensis leaf juice, dimethicone, tocopheryl acetate, panthenol, linoleamidopropyl PG-dimonium chloride phosphate, dimethiconol, sodium lauryl glucose carboxylate, lauryl glucoside, amodimethicone, hydroxypropyl methylcellulose, laureth-9, C11-15 alketh-7, trideceth-12, propylene glycol, sodium chloride, sodium xylenesulfonate, hydroxyethylcellulose, citric acid, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.
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PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
Walgreens
• WALGREENS •
PHARMACIST RECOMMENDED†Compare to the active ingredient
in Selsun Blue®††ITCHY DRY SCALP
DEFENSEDandruff
ShampooPYRITHIONE ZINC 1%
- Daily scalp care
- Moisturizing formula to help
nourish hair & scalp - Formulated to help prevent
& eliminate itchy scalp
& visible flakes*
11 FL OZ (325 mL)
05-4486
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INGREDIENTS AND APPEARANCE
WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE ANTI-DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B) Glycerin (UNII: PDC6A3C0OX) COCO MONOETHANOLAMIDE (UNII: C80684146D) Glycol Distearate (UNII: 13W7MDN21W) Cetyl Alcohol (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) Dimethicone (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Panthenol (UNII: WV9CM0O67Z) LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) Lauryl Glucoside (UNII: 76LN7P7UCU) AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLIDOCANOL (UNII: 0AWH8BFG9A) C11-15 PARETH-7 (UNII: 261HPE0IS3) Trideceth-12 (UNII: YFY3KG5Y7O) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Chloride (UNII: 451W47IQ8X) Sodium Xylenesulfonate (UNII: G4LZF950UR) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Phenoxyethanol (UNII: HIE492ZZ3T) Methylchloroisothiazolinone (UNII: DEL7T5QRPN) Methylisothiazolinone (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4138-01 325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/19/2022 Labeler - Walgreen Company (008965063) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries, INC 255106239 MANUFACTURE(0363-4138)