The following Structured Product Label (SPL) was submitted to the FDA by Abbe Laboratories, Inc. for the product End-zit (NDC 68605-2010). 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 indications & usage, dosage & administration, otc - do not use, otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Intended for use on blemishes only. This advanced formulation is designed to dry and aid in elimination of pimples. It is make-up quality for excellent coverage of the blemish. It is unbelievably effective, clinically tested, dermatologist approved and recommended.
DIRECTIONS: Shake bottle well before each use. Apply directly to blemish only, using applicator. Wait a few moments until slightly dry. Pat with fingertip or clean cotton swab to blend color to skin. Make-up may be applied if desired. Should remain on skin all day. Re-apply at night to clean skin to remain on skin overnight.
NOTE: PERSONS WITH KNOWN SENSITIVITY TO SULFUR SHOULD AVOID USE OF THIS PRODUCT.
KEEP FROM EYES.
DRUG FACTS
ACTIVE INGREDIENT ............ SULFUR 5%
PURPOSE ............. ACNE TREATMENT
WARNINGS:
• For external use only.
• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• Do not get into eyes. If excessive skin irritation deve lops or increases, discontinue use and consult a doctor.
• Keep out of reach of children.
OTHER INGREDIENTS: Isopropyl Alcohol, Water, Zinc Oxide, Propylene Glycol, Camphor, Talc, Sodium Laureth Sulfate, Titanium Dioxide, Diazolidinyl Urea, Methylparaben, Propylparaben. May contain Iron Oxides.
NDC #'s
Light/Medium 68605-2001-2 Medium/Dark 68605-2002-2
Sun Bronze 68605-2003-2 Untinted 68605-2006-2
DIRECTIONS: SHAKE BOTTLE WELL.
APPLY TWICE DAILY DIRECTLY TO
ACNE BREAKOUT. ALLOW TO DRY
FOR 10 SECONDS. PAT TO BLEND.
APPLY MAKE-UP IF DESIRED.
ACTIVE INGREDIENT: SULFUR 5%.
WARNINGS:
AVOID IF ALLERGIC TO SULFUR
AVOID CONTACT WITH EYES
FOR EXTERNAL USE ONLY
KEEP FROM CHILDREN
Manufactured by ABBE Laboratories, Inc.
Farmingdale, NY 11735
Made in the U.S.A.
END-ZIT®
ACNE CONTROL
DRYING LOTION
ABBE
0.62 OZ. (17.57 g)
Product Label (End Zit)
* Please review the disclaimer below.
