Definitions - Legend for The Derm Directory
| Category | Definitions |
|---|---|
 |
New Product. |
 |
Generic equivalent is available |
 |
FDA approved for pediatric use (≤12 years) |
 |
Use in lactating women is 'safe' or 'probably safe' |
 |
Fragrance-free |
 |
Just for men |
 |
Published peer-reviewed studies available |
 |
Prescription required |
 |
Available over-the-counter (retail stores) |
 |
Offered private label |
 |
Recommended by the Skin Cancer Foundation |
 |
Water resistant or waterproof |
FDA-Assigned Pregnancy Category
| Category | Definitions |
|---|---|
Pregnancy Category A |
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). |
Pregnancy Category B |
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
Pregnancy Category C |
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
Pregnancy Category D |
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
Pregnancy Category X |
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. |
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