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XtraCare Anti-Dandruff Hair Cleanse for normal hair

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 20mg in 400mg
Labeler: China Ningbo Shangge Cosmetic Technology Corp.
NDC Code: 58503-028

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  FOR NORMAL HAIR
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-028
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC20 mg  in 400 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
COCO MONOETHANOLAMIDE 
.BETA.-D-GLUCOPYRANOSE 
GLYCERIN 
CARBOMER COPOLYMER TYPE A 
DMDM HYDANTOIN 
TROLAMINE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:58503-028-01400 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/09/2013
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-028)

Revised: 10/2013
 
China Ningbo Shangge Cosmetic Technology Corp.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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