Rejuvaderm Medispa Fading
FDA Label NDC 51325-300

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ellen H Frankle Md Inc for the product Rejuvaderm Medispa Fading (NDC 51325-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, indications & usage, dosage & administration, warnings, general precautions, otc - purpose, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Inactive Ingredient

→ Indications & Usage

→ Dosage & Administration

→ Warnings

→ General Precautions

→ Otc - Purpose

→ Otc - Keep Out Of Reach Of Children

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient: 2% hydroquinone

Inactive Ingredient

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

Indications & Usage

Use: lightens discolorations

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.

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

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.