Tretinoin Topical Gel, Polymeric Porous Microspheres 0.04pct Drug Medication Dosage Information
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Tretinoin: Topical gel, polymeric porous microspheres (0.04%)

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What is this Medicine?

TRETINOIN (TRET i noe in) is a naturally occurring form of vitamin A. It is used on the skin to treat mild to moderate acne.

In-Depth Information
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Tretinoin Microsphere 0.04% Topical Gel

NDC: 665300251
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Acne Vulgaris, Acute Promyelocytic Leukemia (APL)

Sometimes used for but not FDA approved for the following conditions:
Keloids, Ichthyosis, Acne Rosacea, Keratosis Follicularis, Melasma, Actinic Keratosis

Storage Information
Store at controlled room temperature (between 68 and 77 degrees F)
Tretinoin Microsphere 0.04% Topical Gel

Reported Side Effects for Tretinoin Microsphere 0.04% Topical Gel

Unusual Skin Lightening Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Darkened Skin Patches Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Swelling Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Pale Skin Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Dry Skin Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
Skin Redness Incidence:
>10.0%*
Severity: MODERATE
Onset: EARLY
Skin Irritation Incidence:
>10.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
>20.0%*
Severity: MILD
Onset: RAPID
Skin Rash Incidence:
54.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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