ROYAL DANDRUFF DRY SCALP CARE- pyrithione zinc shampoo

Royal dandruff Dry Scalp Care by

Drug Labeling and Warnings

Royal dandruff Dry Scalp Care by is a Otc medication manufactured, distributed, or labeled by Filo America, NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                     Purpose

Pyrithione Zinc       1%                            Anti-dandruff

PURPOSE

Help prevent the scalp's natural moisture balance and gives you great looking hair.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.

INDICATIONS & USAGE

Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.

For best results, use at least twice a week or as directed by a doctor.

For maximum dandruff control, use every time you shampoo.

WARNINGS

For external use only.

Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

DOSAGE & ADMINISTRATION

apply as needed.

INACTIVE INGREDIENT

water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL DANDRUFF DRY SCALP CARE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
glycol stearate (UNII: 0324G66D0E)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ammonium chloride (UNII: 01Q9PC255D)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-300-01	350 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/17/2013

Labeler - Filo America (943873703)

Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.		529047265	manufacture(50438-300)