Our Custom Rx Safety Information

Compound: Estriol 0.03% / Tretinoin 0.1% (Topical)
Dosage Form: Cream/Gel (topical, compounded - not FDA-approved)
Typical Use: Prescriber-directed dermatologic use (off-label).
Usual Directions (example): Apply a thin layer to the affected area once nightly; use moisturizer and daily
broad-spectrum sunscreen (SPF 30+). Adjust per prescriber.

Key Components & Risks
- Estriol (estrogen) 0.03%: Estrogen-class risks; systemic absorption possible; avoid in estrogen-dependent
cancers, pregnancy, thromboembolic disease.
- Tretinoin 0.1%: Skin irritation/dryness; photosensitivity; avoid in pregnancy; caution with concomitant irritating
agents.

Regulatory Status & Evidence
- Estriol-containing products are not FDA-approved; compounded estriol is available via compounding pharmacies.
FDA does not have evidence establishing safety/efficacy for estriol products.
- Professional societies (e.g., ACOG, NAMS, Endocrine Society) advise against routine use of compounded
bioidentical hormones when FDA-approved options exist.

Contraindications
- Pregnancy or breastfeeding (avoid tretinoin and systemic estrogen exposure).
- Known or suspected estrogen-dependent neoplasia (e.g., breast, endometrial) or undiagnosed abnormal genital
bleeding.
- Active or history of thromboembolic disease (DVT/PE), arterial thromboembolic disease (stroke/MI).
- Severe hepatic impairment or known hypersensitivity to components.
- Severely eczematous or sunburned skin: defer use until resolved.

Warnings & Precautions
- Photosensitivity: Tretinoin increases sun sensitivity; use daily broad-spectrum sunscreen (SPF >= 30).
- Irritation: Start every other night, then increase as tolerated; use gentle cleanser and moisturizer.
- Systemic absorption of topical estrogens can occur; apply sparingly to intact skin and avoid occlusion.
- Discontinue and contact prescriber for severe irritation, swelling, blistering, or estrogen-related adverse effects.

Drug/Skincare Interactions
- Avoid simultaneous application with other irritants (alpha/beta hydroxy acids, astringents).
- Benzoyl peroxide used concurrently may inactivate or irritate tretinoin; separate application times if prescribed
together.
- Concomitant use with systemic hormone therapy requires monitoring for additive estrogen effects.

Adverse Effects (Selected)
- Local: erythema, peeling, dryness, burning/stinging, pruritus; transient worsening in initial 2-4 weeks is common.
- Estrogenic effects: breast tenderness, headache, nausea; rare thromboembolic risk if absorbed systemically.
- Photosensitivity reactions (sunburn).

Monitoring (Per Prescriber)
- Clinical response/tolerability within 4-8 weeks.
- Consider baseline and follow-up review of estrogen-related risks (e.g., VTE history, breast cancer risk).
- If long-term use or large surface areas: periodic evaluation for estrogen effects may be warranted.

Patient Counseling Points
- Apply a pea-sized amount to clean, dry skin at night; avoid eyes, lips, mucosa, and broken skin.
- Use moisturizer; start every other night if sensitive, then increase to nightly as tolerated.
- Use sunscreen daily and limit sun exposure.
- Do not use if pregnant, planning pregnancy, or breastfeeding.
- Report unexpected vaginal bleeding, breast tenderness, severe skin irritation, or clot symptoms.

Storage & Handling
- Store at room temperature (20-25 C / 68-77 F).
- Protect from heat and light; keep container tightly closed.
- For external use only. Keep out of reach of children and pets.

References (Selected)
- Tretinoin topical labeling (DailyMed).
- FDA: Menopause page - estriol not FDA-approved; compounded products lack FDA evaluation.
- ACOG Clinical Consensus (2023): Compounded bioidentical hormone therapy - not recommended when
FDA-approved options exist.
- Estrogen product labeling: warnings for systemic absorption and contraindications.

Disclaimer: For clinical reference by licensed professionals. Not a substitute for prescriber judgment or official
labeling.