OTC Medication Information: XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter

XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER- pyrithione zinc lotion/shampoo
Rejoice International Inc.

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)

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XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER
pyrithione zinc lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-025
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
STEARYL ALCOHOL
GLYCERIN
CETRIMONIUM CHLORIDE
CETYL ALCOHOL
POLYQUATERNIUM-37 (3000 MPA.S)
DMDM HYDANTOIN
C13-16 ISOPARAFFIN
TRIDECETH-6
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
COCOS NUCIFERA WHOLE
SHEA BUTTER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57337-025-01 400 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 — Rejoice International Inc. (078741245)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (57337-025)

Revised: 09/2019 Rejoice International Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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