FDA Label for Teatrical Pro-aclarant Skin Lightening
View Indications, Usage & Precautions
Teatrical Pro-aclarant Skin Lightening Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
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