13.5OZ 2 IN 1 DANDRUFF HAIR CLEANSE AND CONDITIONER - SHEA AND COCOA BUTTER- pyrithione zinc shampoo

13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter by

Drug Labeling and Warnings

13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter by is a Otc medication manufactured, distributed, or labeled by Rejoice International Corp., China Ningbo Shangge Cosmetics Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione Zinc 0.5%

Purpose

Anti-dandruff

Use

Helps prevent recurrence of flaking and itching associsted with dandruff.

Warnings

For external use only

When using this product

Avoid contact with 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 of this products as directed.

Keep out of reach of children

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

Directions

Wet hair, massage onto scalp, rinse. Repeat if desired. For best resultd use at least twice a week or as directed by a doctor.

Other information

Store at room temperature.

Inactive ingredients

Water

Sodium Laureth Sulfate

Cocamidopropyl Betaine

Sodium Chloride

Cocamide MEA

Fragrance

Gellan Gum

Citric Acid

Zinc Chloride

Calcium Chloride

Glycerin

Disodium EDTA

Aloe Barbadensis Leaf Extract

Methylchloroisothiazolinone

Methylisothiazolinone

Yellow 5

Red 33

label

INGREDIENTS AND APPEARANCE

13.5OZ 2 IN 1 DANDRUFF HAIR CLEANSE AND CONDITIONER - SHEA AND COCOA BUTTER 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-179
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID (UNII: 2968PHW8QP)
RED 33 (UNII: 9DBA0SBB0L)
GELLAN GUM (UNII: 7593U09I4D)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
YELLOW 5 (UNII: I753WB2F1M)
COCAMIDE MEA (UNII: C80684146D)
ZINC CHLORIDE (UNII: 86Q357L16B)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-179-01	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/17/2025

Labeler - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(57337-179)