TEATRICAL PRO-ACLARANT SKIN LIGHTENING- hydroquinone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)

Available from:

Genomma Lab USA

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

TEATRICAL PRO-ACLARANT SKIN LIGHTENING- HYDROQUINONE CREAM
GENOMMA LAB USA
_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._
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T EATRICAL PRO-ACLARANT SKIN LIGHTENING CREAM
_DRUG FACTS_
ACTIVE INGREDIENT
Hydroquinone 2%
PURPOS E
Skin Lightener
US E
Lightens dark (brownish) spots, blotches, freckles and discolorations
of the skin.
WARNINGS
FOR EXTERNAL USE ONLY
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.
STOP USE AND CONSULT A DOCTOR IF skin irritation becomes severe.
IF PREGNANT OR BREAST-FEEDING, ask a doctor before use.
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?
Call toll free 1-877-994-3666
Distributed by:
Genomma Lab USA Inc., Houston,
TX 77027
PRINCIPAL DISPLAY PANEL - 48 G TUBE CARTON
teatrica