ROYAL DANDRUFF DRY SCALP CARE- pyrithione zinc shampoo 
Filo America

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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Drug Facts

Active Ingredient                                     Purpose

Pyrithione Zinc       1%                            Anti-dandruff

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

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.

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.

For external use only.

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

apply as needed.

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

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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 DEA Schedule     
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)

Revised: 9/2013
Document Id: f132d80e-721f-4219-963e-43764aaa88bf
Set id: 73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3
Version: 1
Effective Time: 20130917
 
Filo America