OTC Medication Information: XtraCare 2 in 1 Hair Cleanse and Condition Green Apple

XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION GREEN APPLE- pyrithione zinc 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

Uses

Helps prevent recurrence of flaking and itching associated with dandruff.

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

XtraCare Pyrithione Zinc

2 in 1 Dandruff

Shampoo + Conditioner

Green Apple

helps to relieve itching, dryness, and flaking

Warnings

For external use only

When using this product

Avoid contact wiht 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, carbomer, glycerin, fragrance, citric acid, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone.

Other Information

Store at 20C to 25C (68F to 77F)

Questions/Comments?  1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168, USA

MADE IN CHINA

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XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION GREEN APPLE
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-065
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
COCO MONOETHANOLAMIDE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
ALOE VERA LEAF
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57337-065-01 400 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 08/27/2014
Labeler — Rejoice International Inc. (078741245)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (57337-065)

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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