OTC Medication Information: XtraCare Foaming Facial Cleanser

XTRACARE FOAMING FACIAL CLEANSER- triclosan gel
Rejoice International

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

Triclosan 0.25% ……………………… Antiseptic

XtraCare (oil-free) foaming facial cleanser

medicated to kill problem-causing bacteria without overdrying

Compare to Clean & Clear® Foaming Facial Cleanser

8 fl. oz. (237 mL)

oil free foaming facial cleanser

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

Use  to help reduce bacteria on the skin

Warnings For external use only

When using this product avoid contact with eyes. if eye contact occurs, immediately flush with water.

Stop use and ask a doctor if

• excessive skin irritation develops or condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Directions

mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

Other Information

Do not store where water may enter bottle.

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

XTRACARE FOAMING FACIAL CLEANSER triclosan gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-036 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (TRICLOSAN) TRICLOSAN 1 mg in 237 mg

Inactive Ingredients Ingredient Name Strength WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE POLYOXYL 40 CASTOR OIL DMDM HYDANTOIN EDETATE DISODIUM CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLPARABEN FD&C YELLOW NO. 5 D&C RED NO. 33

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57337-036-01 237 mg in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/26/2013

Labeler — Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture (57337-036)

Revised: 09/2019 Rejoice International