OTC Medication Information: I-MAX LIGHTENING 5

I-MAX LIGHTENING 5- hydroquinone cream
MAXLIFE USA, 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 INGREDIENTS:
HYDROQUINONE USP 2%

PURPOSE:

SKIN LIGHTENING

USES:

FOR THE GRADUAL FADING OF DARK AREAS OF THE SKIN.

WARNINGS:

AVOID CONTACT WITH EYES. SOME USERS MAY EXPERIENCE MILD SKIN IRRITATION.

IF IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.

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.

DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

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 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.

QUESTIONS? 1-323-733-7033

KEEP OUT OF REACH OF CHILDREN.

5_Lightening_LBL
(click image for full-size original)

I-MAX LIGHTENING 5
hydroquinone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
C13-14 ISOPARAFFIN
CETYL ALCOHOL
ETHYLHEXYLGLYCERIN
ETHYLHEXYL STEARATE
GLYCERIN
GLYCERYL MONOSTEARATE
GLYCOLIC ACID
ISOPROPYL MYRISTATE
LAURETH-7
NIACINAMIDE
PANTOTHENIC ACID
PEG-100 STEARATE
PHENOXYETHANOL
POLYACRYLAMIDE (10000 MW)
PYRIDOXINE HYDROCHLORIDE
SODIUM HYDROXIDE
SODIUM METABISULFITE
TETRAHEXYLDECYL ASCORBATE
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42952-201-12 59 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 09/18/2012
Labeler — MAXLIFE USA, INC. (785111431)

Revised: 10/2018 MAXLIFE USA, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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