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 Mission Series Inc. dba Prestige Beauty Care, PATCOS COSMETICS (INDIA) PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

 Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use

helps protect the scalp's natural moisture balance and gives you great looking hair.   

Warnings

For external use only.

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use as directed.

Keep out of reach of children

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

Directions

• 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.

Inactive Ingredients

Water, Sodium lauryl Ether Sulfate, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Cocomonoethanolamide, Ethylene Glycol Monostearate, Sodium Xylenesulfonate, Sodium Chloride, Zinc Carbonate, Dimethicone, Cetrimonium Chloride, Fragrance, Sodium Benzoate, Gaur Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis ( Sweet Almond )Oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl No. 42090

SPL UNCLASSIFIED SECTION

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in India

Product label

INGREDIENTS AND APPEARANCE

ROYAL DANDRUFF DRY SCALP CARE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73597-026
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)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CARBONATE (UNII: EQR32Y7H0M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALMOND OIL (UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73597-026-10	24 in 1 CARTON	03/15/2023
1		296 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/15/2023

Labeler - Mission Series Inc. dba Prestige Beauty Care (117190866)

Establishment
Name	Address	ID/FEI	Business Operations
PATCOS COSMETICS (INDIA) PRIVATE LIMITED		675973979	manufacture(73597-026)