Label: TEATRICAL PRO-ACLARANT SKIN LIGHTENING- hydroquinone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50066-072-01 - Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 22, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults: Apply a small amount as a thin layer on the affected area twice daily, or use 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 when used on very dark skin.
- Children under 12 years of age: Do not use unless directed by a doctor.
- Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
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INGREDIENTS AND APPEARANCE
TEATRICAL PRO-ACLARANT SKIN LIGHTENING
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 20 mg in 1 g Inactive Ingredients Ingredient Name Strength Mineral oil (UNII: T5L8T28FGP) Isopropyl myristate (UNII: 0RE8K4LNJS) Propylene Glycol (UNII: 6DC9Q167V3) Cetyl alcohol (UNII: 936JST6JCN) Polysorbate 60 (UNII: CAL22UVI4M) PEG-100 stearate (UNII: YD01N1999R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-072-01 1 in 1 CARTON 04/22/2020 1 48 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part358A 04/22/2020 Labeler - Genomma Lab USA (832323534)