MIRACLE FADE- hydroquinone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Available from:

Concept Laboratories, Inc.

INN (International Name):

HYDROQUINONE

Composition:

HYDROQUINONE 1.695 g in 113 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Lightener for the gradual fading of dark (brownish) discolorations in the skin such as - freckles - age and liver spots - pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

Authorization status:

OTC monograph not final

Summary of Product characteristics

MIRACLE FADE- HYDROQUINONE CREAM
CONCEPT LABORATORIES, INC.
_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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MIRACLE
FADE CREAM
Drug Facts
ACTIVE INGREDIENT
Hydroquinone 1.5%
PURPOS E
Skin Lightener
US ES
for the gradual fading of dark (brownish) discolorations in the skin
such as
freckles
age and liver spots
pigment in the skin that may occur in pregnancy or from the use of
oral contraceptives
WARNINGS
For external use only.
avoid contact with eyes. If eye contact occurs flush thoroughly with
water.
some users of this product may experience a mild skin irritation. If
skin irritation becomes severe,
stop use and consult a doctor
do not use on children under 12 years of age unless directed by a
doctor
if pregnant or nursing, seek the advice of a health professional
before using
When using this product do not use on cracked, irritated or inflamed
skin
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.
for sensitive skin, test product on a small section of your skin
inside your elbow
INACTIVE INGREDIENTS
Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Mineral Oil,
Ceteareth-20, Isopropyl Myristate,
Glycerin, Petrolatum, Butyrospermum Parkii (Shea Butter), Sodium
Metabisulfite, Propylene Glycol,
DMDM Hydantoin, Methylparaben, Propylparaben, Citric Acid, Glycolic
Acid, Ascorbic Acid,
Glycyrrhiza Glabra (Licorice) Root Extract, Disodium EDTA, Fragrance.
OTHER INFORMATION
For sensitive skin, test product on a small section of your skin
inside your elbow. If no irritation
develops after 24 ho