LUCKY 2IN1 CLASSIC- pyrithione zinc shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)

Available from:

Delta Brands Inc

INN (International Name):

PYRITHIONE ZINC

Composition:

PYRITHIONE ZINC 0.3 mL in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-dandruff • helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff. if condition does not improve or worsen after regular use of this product as directed

Authorization status:

OTC monograph final

Summary of Product characteristics

LUCKY 2IN1 CLASSIC- PYRITHIONE ZINC SHAMPOO
DELTA BRANDS 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._
----------
DRUG FACTS
_ACTIVE INGREDIENT_
Pyrithione zinc 0.3%
_PURPOSE_
Anti-dandruff
_USES_
• helps to treat flakes, itch, irritation, oilness or dryness caused
by dandruff.
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
•avoid contact with eyes • if contact occurs, rinse eyes with
plenty of water.
STOP USE AND ASK A DOCTOR
if condition does not improve or worsen after regular use of this
product as directed
KEEP OUT OF REACH OF CHILDREN
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN If swallowed get
medical help or contact a Poison
Control Center right away.
_DIRECTIONS_
•wet hair, •squeeze small amount into palm •lather, •rinse
well
_INACTIVE INGREDIENTS_
acrylates copolymer, benzyl alcohol, cocamidopropyl betaine, cocamide
DEA, cocamide MEA, coco-
glucoside, dimethicone, FD&C blue no. 1, fragrance, glycol distearate,
laureth-10,
methylchloroisothiazolinone, methylisothiazolinone, polyquaternium-10,
sodium chloride, sodium
laureth sulfate, styrene/acrylates coploymer,tetrasodium EDTA,
triethanolamine, water, zinc acetate
PACKAGE LABEL
LUCKY 2IN1 CLASSIC
pyrithione zinc shampoo
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:20 276 -0 46
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9
53O2RHZ5)
PYRITHIONE ZINC
0 .3 mg in 10 0 mL
Delta Brands Inc
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)
CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)
CO CO GLUCO SIDE (UNII: ICS79 0 225B)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
GLYCO L DISTEARATE (UNII: 13W7MDN