OLIVIA QUIDO FIRM AND FADE II- hydrocortisone, hydroquinone, tretinoin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Available from:

O Skin Pharmaceutical Corporation

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 1.1Indication OLIVIA QUIDO FIRM & FADE II Cream is a combination of hydrocortisone (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and a tretinoin (a retinoid) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. 1.2 Limitations of Use The safety and efficacy of OLIVIA QUIDO FIRM & FADE II Cream in pregnant women and nursing mothers have not been established. OLIVIA QUIDO FIRM & FADE II Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to OLIVIA QUIDO FIRM & FADE II Cream in pregnancy, she should be counseled on the risk

Product summary:

16 HOW SUPPLIED OLIVIA QUIDO FIRM & FADE II Cream is light yellow in color, and supplied in 28.35 g airless bottle, NDC 72864-563-01.

Authorization status:

unapproved drug other

Summary of Product characteristics

OLIVIA QUIDO FIRM AND FADE II- HYDROCORTISONE, HYDROQUINONE,
TRETINOIN CREAM
O SKIN PHARMACEUTICAL CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLIVIA QUIDO FIRM &
FADE II CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OLIVIA QUIDO
FIRM & FADE I CREAM.
OLIVIA QUIDO FIRM & FADE I CREAM (HYDROCORTISONE, HYDROQUINONE,
TRETINOIN) CREAM,
1%/8%/0.1% FOR TOPICAL USE. FOR TOPICAL USE
INITIAL U.S. APPROVAL: XXXX
INDICATIONS AND USAGE
OLIVIA QUIDO FIRM & FADE II Cream is a combination of hydrocortisone
(a corticosteroid), hydroquinone (a
melanin synthesis inhibitor), and a tretinoin (a retinoid) that is
indicated for the gradual bleaching of
hyperpigmented skin conditions age and liver spots, freckles, and
other unwanted areas of melanin
hyperpigmentation, in the presence of measures for sun avoidance,
including the use of sunscreen. (1) (1)
DOSAGE AND ADMINISTRATION
Apply a thin film to the affected area once daily at night or as
directed by a doctor. (2)
During the day, use O Skin Sunscreen SPF-50, and wear protective
clothing. Avoid sunlight exposure. (2)
(2)
DOSAGE FORMS AND STRENGTHS
Cream, 1%/6%/0.1%. Each gram of OLIVIA QUIDO FIRM & FADE II Cream
contains 10.0 mg of
hydrocortisone, 60.0 mg of hydroquinone, and 1.0 mg of tretinoin. (3)
(3)
CONTRAINDICATIONS
(4)
OLIVIA QUIDO FIRM & FADE II Cream is contraindicated in individuals
with a history of hypersensitivity to
this product or any of its components. (4) (4)
WARNINGS AND PRECAUTIONS
If anaphylaxis, asthma or other clinically significantly
hypersensitivity reactions occur, institute appropriate
therapy and discontinue OLIVIA QUIDO FIRM & FADE II Cream. Allergic
contact dermatitis may also occur.
(5.1)
OLIVIA QUIDO FIRM & FADE II Cream contains hydroquinone, which may
produce exoge