Label at a glance#

ProductRejuvaderm medispa fading

Active ingredienthydroquinone

Label structure9 sections

Contacts and useful links#

Websitewww.rejuvadermmedispa.com

www.rejuvadermmedispa.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 2% hydroquinone

INACTIVE INGREDIENT SECTION

Also contains: Glycolic acid, Sodium metabisulfite, Kojic acid, Sodium Bisulfite.

INDICATIONS & USAGE SECTION

Use: lightens discolorations

DOSAGE & ADMINISTRATION SECTION

Directions: adults: apply a thin layer on the affected area twice daily or 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 nt be noticeable when used on very dark skin. Avoid unnecessary sun exposure and use a sunscreen while using and after using this product to prevent darkening from reoccurring.

WARNINGS SECTION

Warnings: For External Use Only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. some users of this product might experience a mild skin irritation.If skin irritation becomes severe, stop use and consult a doctor. Do not use on children under 12 years of age unless directed by a doctor. If
pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

GENERAL PRECAUTIONS SECTION

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

OTC - PURPOSE SECTION

Purpose: Skin Bleaching

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rejuvaderm Medispa

reawakens the essence that is you

Fading Lotion

2% hydroquinone

2 fl oz. (60 ml)

401944skin

wwwriskindoc.com

www.rejuvadermmedispa.com

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROQUINONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51325-300-03	2019-10-21	C162847	48780-1	956f9ecf-ddf7-621f-e053-dbdaa90a74ad	Rejuvaderm medispa Fading

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51325-300-03	Rejuvaderm medispa fading	60 mL in 1 BOTTLE	LOTION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51325-300	REJUVADERM MEDISPA FADING (HYDROQUINONE) LOTION [ELLEN H FRANKLE MD INC]	1	Legacy NDC, 1 package rows	20100826_aac39726-75f8-4adb-86e2-ce2a635b63d0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
hydroquinone	ACTIVE INGREDIENT	XV74C1N1AE	1
hydroquinone	ACTIVE MOIETY	XV74C1N1AE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Rejuvaderm medispa fading
hydroquinone

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51325-300	51325-300-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
hydroquinone	XV74C1N1AE	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d4552d19-6285-4d4f-bee0-4d18b4fd1001			aac39726-75f8-4adb-86e2-ce2a635b63d0	2010-08-03	Warnings	Exact identifier spl id: d4552d19-6285-4d4f-bee0-4d18b4fd1001 spl set id: aac39726-75f8-4adb-86e2-ce2a635b63d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.