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

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.