Otc - Active Ingredient
Hydroquinone 2%
Skin Lightening
FDA Label NDC 14222-1615
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields, Llc. for the product Skin Lightening (NDC 14222-1615). 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, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Lightening
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
if swallowed, get medical help or contact a poison control center immediately.Warnings
avoid contact with eyes.
some
user of this product may experience a mild skin irritation. if skin
irritation becomes severe , stop use and consult a physician.
do not use if pregnant or nursing.
do not use on children under 12 years of age unless directed by a physician.Dosage & Administration
apply evenly to the entire face with a fresh gauze pad, avoiding the
eye area. do not rinse off, allow to dry. use once daily and increase
to twice daily as tolerated.
Adult: apply a small amount as a
think layer in affected area once or twice daily, or use as directed by
a physician . if no improvement is seen after three 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.
children under 12 years of age: do not use unless directed by a physician.
Inactive Ingredient
Water (aqua), Ethoxydiglycol, Hamamelis Virgiana ( Witch Hazel) Water, Methylpropanediol, Alcohol Denat, Polysorbate 20, Butylene Glycol, Aminopropyl Ascorbyl Phosphate, Foeniculum Vulgare ( Fennel) Seed Extract, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi (leaf) Extract, PEG-12, Dimethicone, Arnica Montana Flower Extract, Zinc Phenolsulfonate, Kojic Acid, Citrus Medica Limonum ( Lemon) Peel Extract, Sodium Salicylate, Citric Acid, Sodium Sulfite, Sodium Metabisulfite, DMDM Hydantoin, Fragrance, Yellow 5, Yellow 6
Image Of Box (Box)
Indications & Usage
for external use only
Package Label.Principal Display Panel
Rodan and Fields
Reverse
Dermatologist developed skin lightening toner
125 mL/ 4.2 Fl. Oz.
Image Of Bottle (Bottle)
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