Otc - Active Ingredient
Active Ingredient Purpose
Triclosan 0.25% ........................... Antiseptic
Xtracare Foaming Facial Cleanser Gel
FDA Label NDC 57337-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Foaming Facial Cleanser (NDC 57337-036). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Use to help reduce bacteria on the skin
Warnings
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
Dosage & Administration
Directions
mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.
Other Safety Information
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 Ingredient
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
* Please review the disclaimer below.
