Principal Display Panel
Fadecreme (Fadecreme)
Medicated Fade Creme With Sunscreen
FDA Label NDC 16708-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluefield Associates, Inc. for the product Medicated Fade Creme With Sunscreen (NDC 16708-002). 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 principal display panel, active ingredient, purpose, uses:, warnings, do not use on, keep out of the reach of children., questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydroquinone U.S.P. 2%
Octinoxate 2.5%
Purpose
Skin Lightener
Sunscreen
Uses:
- Lightens dark discolorations on the skin such as age spots, dark patches or freckles that may occur from medication, pregnancy or exposure to the elements.
- Contains a sunscreen to help prevent darkening from reoccurring.
Warnings
For External use only. Avoid contact with eyes. Some users of this product may 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.
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a doctor before use.
Questions Or Comments?
1-800-423-0306 or [email protected]
Directions
- Spread a thin layer into patches on face, hands, arms or body..
- Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident.
- Not for use on children under 12 except on doctor's intructions.
Inactive Ingredients
Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).
* Please review the disclaimer below.
