Label: MIRACLE FADE- hydroquinone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 64058-716-34 - Packager: Concept Laboratories, 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 June 6, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
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.
- for sensitive skin, test product on a small section of your skin inside your elbow
-
Inactive ingredients
Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Mineral Oil, Ceteareth-20, Isopropyl Myristate, Glycerin, Petrolatum, Butyrospermum Parkii (Shea Butter), Sodium Metabisulfite, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Citric Acid, Glycolic Acid, Ascorbic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Disodium EDTA, Fragrance.
-
Other Information
- For sensitive skin, test product on a small section of your skin inside your elbow. If no irritation develops after 24 hours proceed with application.
- Close product lid tightly after each use. Cream may darken when exposed to air. Product performance will not be affected.
- Do not use this product in combination with externally applied products containing resorcinol, phenol, salicylic acid or any type of acne product unless directed by a doctor.
- Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Jar Label
-
INGREDIENTS AND APPEARANCE
MIRACLE FADE
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-716 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 1.695 g in 113 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SHEA BUTTER (UNII: K49155WL9Y) GLYCERIN (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCOLIC ACID (UNII: 0WT12SX38S) DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM METABISULFITE (UNII: 4VON5FNS3C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-716-34 113 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part358A 04/29/2014 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-716)