IMAGE MD LIGHTENING RX- hydroquinone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Available from:

Allure Labs, Inc.

INN (International Name):

HYDROQUINONE

Composition:

HYDROQUINONE 40 mg in 1 mL

Prescription type:

OTC DRUG

Therapeutic indications:

INDICATIONS AND USAGE SECTION: For Physician Dispensary Only

Authorization status:

OTC monograph final

Summary of Product characteristics

IMAGE MD LIGHTENING RX - HYDROQUINONE CREAM
ALLURE LABS, 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._
----------
DRUG FACTS
INDICATIONS AND USAGE SECTION:
For Physician Dispensary Only
An effective lightening creme that diminish facial and body
discolorations.
DIRECTIONS:
Apply to affected areas in the evening. Apply a sunblock during the
day, or as directed by a physician.
Paraben-free
Contains Vitamin C and E
ACTIVE INGREDIENTS:
Hydroquinone 4%
INACTIVE INGREDIENTS:
Water, Glyceryl Monostearate, Polyoxyl 100 Stearate, Butylene Glycol,
Stearyl Alcohol, Stearic Acid,
Caprylic and Capric Triglyceride, Linoleic Acid, Soy Phospholipids,
Dimethicone, C12-15 Alkyl
Benzoate, Xanthan Gum, Magnesium Aluminum Silicate, Cetyl Alcohol,
Stearyl Alcohol, Glycerin,
Licorice, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Lactic
Acid, Disodium EDTA,
Dipotassium Glycyrrizinate, Vitamin E, Sodium Metabisulfite,
Fragrance-Orange.
WARNING:
For external use only.
Keep out of reach of children
DISTRIBUTOR:
Image International
Palm Beach, FL 33411 USA
IMAGE OF PRINCIPAL DISPLAY PANEL:
IMAGE MD LIGHTENING RX
hydroquinone cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 2742-40 46
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO Q UINO NE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
HYDROQUINONE
40 mg in 1 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 2742-40 46 -1
29 .6 mL in 1 TUBE
MARKETING INFORMATION
Allure Labs, Inc.
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt358
0 1/0 1/20 10
LABELER -
Allure Labs, Inc. (926831603)
Revised: 7/2010