OTC Medication Information: XtraCare Anti-Dandruff Hair Cleanse Cocoa and Shea Butter

XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCOA AND SHEA BUTTER- pyrithione zinc shampoo
China Ningbo Shangge Cosmetic Technology Corp.

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.

Active Ingredient Purpose

Pyrithione zinc 0.5% ……………… Anti-dandruff

XtraCare Anti-Dandruff Shampoo + pyrithione zinc

nourishing coconut & shea butter

fight flakes leaving hair healthy & shiny

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Uses  helps prevent recurrence of flaking and itching associated with dandruff.

Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

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 product as directed.

Directions

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

Inactive Ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, lauryl methyl gluceth-10, glycerin, carbomer, DMDM hydantoin, fragrance, triethanolamine, disodium EDTA, cocos nucifera (coconut) fruit extract, shea nut butter.

Other information

store at 20°C to 25°C (68° to 77°F)

XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCOA AND SHEA BUTTER pyrithione zinc shampoo

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-024 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 20 mg in 400 mg

Inactive Ingredients Ingredient Name Strength WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE COCO MONOETHANOLAMIDE .BETA.-D-GLUCOPYRANOSE GLYCERIN CARBOMER COPOLYMER TYPE A DMDM HYDANTOIN TROLAMINE EDETATE DISODIUM COCOS NUCIFERA WHOLE SHEA BUTTER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58503-024-01 400 mg in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/09/2013

Labeler — China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture (58503-024)

Revised: 11/2022 China Ningbo Shangge Cosmetic Technology Corp.