PYRITHIONE ZINC shampoo

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cosmetic Dermatology Research Institute, LLC.

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Status autoryzacji:

OTC monograph final

Charakterystyka produktu

PYRITHIONE ZINC- PYRITHIONE ZINC SHAMPOO
COSMETIC DERMATOLOGY RESEARCH INSTITUTE, 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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71440-001-08
PYRITHIONE ZINC
pyrithione zinc shampoo
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71440-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC -
UNII:R953O2RHZ 5)
PYRITHIONE ZINC
2.41 g
in 237 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PANTHENOL (UNII: WV9CM0O67Z)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII:
0L414VCS5Y)
LINALOOL, (+)- (UNII: F4VNO44C09)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDE (UNII: 3YXD33R71G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PRODUCT CHARACTERISTICS
COLOR
blue
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:71440-001-
08
237 mL in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2021
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part358H
03/07/2016
LABELER -
Cosmetic Dermatology Research Institute, LLC. (833043586)
REGISTRANT -
Chemco Corporation. (032495954)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Chemco Corporation
032495954
manufacture(71440-001)
Cosmetic Dermatology Research Institute, LLC.
Revised: 5/2022