XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS- pyrithione zinc lotion/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.

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XtraCare Anti-Dandruff Conditioner

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)

label image

XTRACARE ANTI-DANDRUFF CONDITIONER  MINT AND EUCALYPTUS
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 400 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
SHEA BUTTER (UNII: K49155WL9Y)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-027-01400 mg in 1 BOTTLE; Type 0: Not a Combination Product10/09/2013
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/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-027)

Revised: 9/2019
Document Id: 9261ee35-189b-7431-e053-2995a90a08ed
Set id: 17fc8bb5-2666-40cf-8d58-a8b10f3c6a0a
Version: 2
Effective Time: 20190912
 
China Ningbo Shangge Cosmetic Technology Corp.