Otc - Active Ingredient
2% Hydroquinone ..... Skin Lightener
1.5% Padimate O.......Subscreen
Ultra Glow Fade
FDA Label NDC 58318-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Keystone Laboratories for the product Ultra Glow Fade (NDC 58318-008). 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 - keep out of reach of children, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Purpose
Skin lightener
Indications & Usage
Skin Lightener
Sunscreen
Warnings
Warnings:
For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
Adults: Apply a small amount in 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 not be noticeable on very dark skin.
Other Safety Information
Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.
Distributed by
KEYSTONE LABORATORIES © 2013
www.keystone-labs.com
1-800-772-8860 / Memphis, TN 38101-2026
MADE IN U.S.A.
PM-LB 0011
Inactive Ingredient
Inactive Ingredients:
water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, mineral oil, sodium metabisulfite, fragrance, steareth 20, methylparaben, butylhydoxytoluene, prophyl gallate, sodium sulfite, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid, aloe barbadensis (Leaf Juice)
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