Label: I-MAX LIGHTENING L- hydroquinone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42952-203-12 - Packager: MAXLIFE USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 9, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
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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.
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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.
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
ALPHA ARBUTIN, C13-14 ISOPARAFFIN, CETYL ALCOHOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL STEARATE, GLYCERIN, GLYCERYL STEARATE, GLYCOLIC ACID, ISOPROPYL MYRISTATE, LAURETH-7, NIACINAMIDE, PANTOTHENIC ACID, PEG-100 STEARATE, PHENOXYETHANOL, PHENYLETHYL RESORCINOL, POLYACRYLAMIDE, PYRIDOXINE HCL, SODIUM HYDROXIDE, SODIUM METABISULFITE, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), XANTHAN GUM.
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
I-MAX LIGHTENING L
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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) ALPHA-ARBUTIN (UNII: 72VUP07IT5) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42952-203-12 59 g in 1 TUBE; Type 0: Not a Combination Product 09/18/2012 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)
