Otc - Active Ingredient
ACTIVE INGREDIENTS:
HYDROQUINONE USP 2%
I-max Lightening 5
FDA Label NDC 42952-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maxlife Usa, Inc. for the product I-max Lightening 5 (NDC 42952-201). 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, indications & usage, warnings, otc - stop use, other safety information, pediatric use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE:
SKIN LIGHTENING
Indications & Usage
USES:
FOR THE GRADUAL FADING OF DARK AREAS OF THE SKIN.
Warnings
WARNINGS:
AVOID CONTACT WITH EYES. SOME USERS MAY EXPERIENCE MILD SKIN IRRITATION.
Otc - Stop Use
IF IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.
Other Safety Information
THIS PRODUCT IS NOT INTENDED FOR USE IN THE PREVENTION OF SUNBURN AND CONTAINS AN ALPHA HYDROXY ACID (AHA) THAT MAY INCREASE YOUR SKIN'S SENSITIVITY TO THE SUN AND PARTICULARLY THE POSSIBILITY OF SUNBURN. SUN EXPOSURE SHOULD BE LIMITED BY USING A SUNSCREEN AGENT OR PROTECTIVE CLOTHING TO COVER BLEACHED SKIN AFTER TREATMENT IS COMPLETED TO PREVENT DARKENING FROM REOCCURING.
Pediatric Use
DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
Dosage & Administration
DIRECTIONS:
ADULTS: APPLY A SMALL AMOUNT AS A THIN LAYER ON THE AFFECTED AREA TWICE DAILY, OR USE AS DIRECTED BY A DOCTOR. IF NO IMPROVEMENT IS SEEN AFTER 3 MONTHS OF TREATMENT, USE OF THIS PRODUCT SHOULD BE DISCONTINUED. LIGHTENING EFFECT OF THIS PRODUCT MAY NOT BE NOTICEABLE WHEN USED ON VERY DARK SKIN.
CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE UNLESS DIRECTED BY A DOCTOR.
Inactive Ingredient
INACTIVE INGREDIENTS:
C13-14 ISOPARAFFIN, CETYL ALCOHOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL STEARATE, GLYCERIN, GLYCERYL STEARATE, GLYCOLIC ACID, ISOPROPYL MYRISTATE, LAURETH-7, NIACINAMIDE, PANTOTHENIC ACID, PEG-100 STEARATE, PHENOXYETHANOL, POLYACRYLAMIDE, PYRIDOXINE HCL, SODIUM HYDROXIDE, SODIUM METABISULFITE, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), XANTHAN GUM.
Otc - Questions
QUESTIONS? 1-323-733-7033
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Package Label.Principal Display Panel
5_lightening_lbl (5 Lightening Lbl)
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