Otc - Active Ingredient
Active Ingredient: 2% Hydroquinone, 1.5% Padimate O
Ultra Glow Fade
FDA Label NDC 58318-002
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 58318-002). 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
Ultra Glow Fade Cream with Aloe Vera
Warnings
Caution: Discontinue use of this product if skin irritation occurs or is already present. Do not use on children under 12 years of age. Avoid contact with eyes or consumption. Administer a patch test on a small area of the skin before applying cream to larger areas of the skin.
Precautions d'emploi: Cesser l'utilisation du produit en cas d'irritation ou sur une peau deja irritee. Ne pas appliquer sur les enfants de moins de 12 ans. Eviter le contact avec les yeux et ne pas avaler. Realiser un test sur une zone reduite de la peau avand d'appliquer la creme sur des zones plus etendues.
Dosage & Administration
Directions:Apply a small amount on the discolored or affected area twice daily. Results may vary; however, desired results are typically visibile within two weeks of usage. If no improvement is visible within 90 days of treatment, discontinue use of this product.
Conseils d'application: Pour un maximum de resultat, appliquer une petite quantite de creme deux foix par jour sur les zones decolorees ou abimees. Les resultats peuvent varier et sont en general visibles apres deux semaines d'utilisation. En l'absence d'ameliorations visibles dans les 90 jours de traitement, interrompre l'application du produit.
Other Safety Information
KEYSTONE LABORATORIES © 2012
www.keystone-labs.com
1-800-772-8860
Memphis, TN 38101-2026
NW7 3SA London, United Kingdom
MADE IN U.S.A. / FABRIQUE AUX E.-U.
PM-TB 0028
Inactive Ingredient
Other Ingredients:
aqua/water/eau, stearyl steareth, glycerol stearate, propylene glycol, cetyl alcohol, isopropyl myristate, ethylhexyl dimethyl, paraffinum liquidum/mineral oil/huile minerale, sodium metabisulfite, fragrance, steareth 20, methylparaben, tetrsodium edta, sodium sulfite, propylis gallas, methyl alcohol, propylparaben, citric acid, aloe barbadensis (leaf juice).
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