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

I-MAX LIGHTENING 5 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42952-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-7 (UNII: Z95S6G8201)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PANTOTHENIC ACID (UNII: 19F5HK2737)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42952-201-1259 g in 1 TUBE; Type 0: Not a Combination Product09/18/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A09/18/2012
Labeler - MAXLIFE USA, INC. (785111431)

Revised: 10/2018
Document Id: 8c9b94d9-1ae4-4def-bdb0-78aeba442a31
Set id: e874f160-1f05-4f53-8e41-8d41c2b441d8
Version: 6
Effective Time: 20181009
 
MAXLIFE USA, INC.