Skin Lightening Complex
FDA Label NDC 65113-8401

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by G.s. Cosmeceutical Usa, Inc. for the product Skin Lightening Complex (NDC 65113-8401). 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 active ingredients, purpose, indications, warnings, directions, inactive ingredients, other information, principal display panel - 30 g tube label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Hydroquinone (2.0%)

Purpose

skin lightener

Indications

  • reduce dark blotches and spots
  • even out skin tone and reduce skin discoloration

Warnings

For external use only

Directions

  • Apply a thin coat to the affected area twice daily or as directed by your physician
  • Utilize sunscreen daily

Inactive Ingredients

Aqua (Water), Glycolic Acid, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Stearyl Alcohol, C12-C15 Alkyl Benzoate, Hydroxypropyl Starch Phosphate, Dimethicone, Sodium Hydroxide, Myristyl Alcohol, Glyceryl Stearate, Butyl Octyl Salicylate, Myristyl Glucoside, PEG 100 Stearate, Lactic Acid, Dehydroxanthan Gum, Sodium Metabisulfite, Camellia Oleifera Leaf Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Propylene Glycol, Phenoxy ethanol, Glycyrrhiza Glabra (Licorice) Root Extract, Arctostaphylos Uva Ursi Leaf Extract, Tocopheryl Acetate, BHT, Diazolidinyl Urea, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Disodium EDTA.

Other Information

  • Read directions and warnings before use
  • Store at room temperature 68°-77° F (20°-25° C)

Principal Display Panel - 30 G Tube Label

A&D
pharma

Skin
Lightening
Complex
with GLYCOLIC ACID

30 g

Principal Display Panel (30 g Tube Label)

Principal Display Panel (30 g Tube Label)

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