TRETINOPAK- tretinoin, avobenzone, octinoxate, octisalate and titanium dioxide

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Available from:

PureTek Corporation

INN (International Name):

TRETINOIN

Composition:

TRETINOIN 0.25 mg in 1 g

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established. The product should not be used if there is hypersensitivity to any of the ingredients. Sunscreen (Avobenzone 2.5%) Sunscreen (Octinoxate 3%) Sunscreen (Octisalate 3%) Sunscreen (Titanium Dioxide 1.25%) ■ Helps prevent sunburn. ■ If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.

Product summary:

Tretinoin Cream 0.025% is supplied in 20 g (NDC 0472-0117-20) and 45 g (NDC 0472-0117-45) tubes. Storage Conditions: Store below 30°C (86°F).  Avoid freezing. Keep this and all medications out of the reach of children. Manufactured by: G&W NC Laboratories, LLC 1877 Kawai Road Lincolnton, NC 28092 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA FORM NO. 0117 Rev. 10/14 VC4494

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TRETINOPAK- TRETINOIN, AVOBENZONE, OCTINOXATE, OCTISALATE AND TITANIUM
DIOXIDE
PURETEK CORPORATION
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TRETINOPAK™
(TRETINOIN, AVOBENZONE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE)
TRETINOIN CREAM, USP 0.025%
FOR TOPICAL USE ONLY
RX ONLY
DESCRIPTION
Tretinoin Cream, a topical retinoid, contains tretinoin 0.025% by
weight in a hydrophilic cream vehicle
of stearic acid, polyolprepolymer-2, isopropyl myristate, polyoxyl 40
stearate, propylene glycol,
stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene,
and purified water. Chemically,
tretinoin is all-_trans_retinoic acid (C
H 0 ; molecular weight 300.44 vitamin A acid) and has the
following structural formula:
CLINICAL PHARMACOLOGY
Although the exact mode of action of tretinoin is unknown, current
evidence suggests that topical
tretinoin decreases cohesiveness of follicular epithelial cells with
decreased microcomedo formation.
Additionally, tretinoin stimulates mitotic activity and increased
turnover of follicular epithelial cells
causing extrusion of the comedones.
PHARMACOKINETICS :
_In vitro_ and _in vivo_ pharmacokinetic studies with tretinoin cream
indicate that less than 0.3% of the
topically applied dose is bioavailable. Circulating plasma levels of
both tretinoin and isotretinoin are
only slightly elevated above those found in healthy normal controls.
CLINICAL STUDIES
In one vehicle-controlled clinical trial, tretinoin cream 0.025%
applied once daily was more effective
than vehicle in the treatment of facial acne vulgaris of mild to
moderate severity. Percent reductions in
lesion count after treatment for 12 weeks in this study are shown in
the following table:
TretinoinCream, Vehicle
0.025%
Cream
N = 75
N = 58
Noninflammatory Lesions
45%
27%
Inflammatory Lesions
46%
32%
Total Lesions
46%
28%
20
28
2
N = Number of Subjects
INDICATIONS AND USAGE
Tretinoin cream is indicated for topical application in the treatment
of acne vulgaris. The safety and
efficacy of this product in the treatment of other disorders have not
been establishe