HYDROQUINONE SKIN BLEACHING AGENT OILY SKIN- hydroquinone, octinoxate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Ambi Enterprises LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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  - contains a sunscreen to help prevent darkening from reoccurring

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROQUINONE SKIN BLEACHING AGENT OILY SKIN- HYDROQUINONE,
OCTINOXATE CREAM
AMBI ENTERPRISES LLC
_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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FADE CREAM HYDROQUINONE SKIN BLEACHING AGENT OILY SKIN
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Hydroquinone 2%
Octinoxate 2%
_PURPOSE_
Skin bleaching agent
Sunscreen
_USES_
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
contains a sunscreen to help prevent darkening from reoccurring
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
• avoid contact with eyes
• 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
this product is not for use in the prevention of sunburn
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 doctor
sun exposure should be limited by using a sunscreen agent, a sun
blocking agent, or
protective clothing to cover bleached skin after treatment is
completed in order to
prevent darkening from reoccurring
_OTHER INFORMATION_
• for expiration date, see bottom of carton
• store at room temperature
_INACTIVE INGREDIENTS_
water, glycerin, isopropyl myristate, stearic acid, cetyl alcohol,
potassium cetyl
phosphate, betaine, glycerl stearate, PEG-100 stearate sodium