Label: REJUVADERM MEDISPA FADING- hydroquinone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51325-300-03 - Packager: Ellen H Frankle MD 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 August 3, 2010
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
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.
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WARNINGS
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
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REJUVADERM MEDISPA FADING
hydroquinone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51325-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone 1.2 mL in 60 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51325-300-03 60 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 08/01/2010 Labeler - Ellen H Frankle MD Inc (603208240)
