Teatrical Pro-aclarant Skin Lightening
FDA Label NDC 50066-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Teatrical Pro-aclarant Skin Lightening (NDC 50066-072). 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 other, active ingredient, purpose, use, warnings, otc - do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Genomma Lab USA Inc., Houston,
TX 77027

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

Lightens dark (brownish) spots, blotches, freckles and discolorations of the skin.

Warnings

For external use only

Otc - Do Not Use

Do not use on children under 12 years of age unless directed by a doctor.

When Using This Product

  • you may experience mild skin irritation
  • avoid contact with eyes.

Otc - Stop Use

Stop use and consult a doctor if skin irritation becomes severe.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • Keep tightly closed.
  • Store at room temperature.

Inactive Ingredients

water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragance

Questions Or Comments?

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Principal Display Panel - 48 G Tube Carton

teatrical®

PRO-ACLARANT
SKIN LIGHTENING

NIGHT
CREAM

HYDROQUINONE 2%

Lightens dark spots

NET WT 1.7 OZ (48 g)

Principal Display Panel (48 g Tube Carton)

Principal Display Panel (48 g Tube Carton)

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