Active Ingredient
Micronized Estriol 0.1%
Lemoto Bioidentical Estrogen Vaginal Cream
FDA Label NDC 87786-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Lemoto Bioidentical Estrogen Vaginal Cream (NDC 87786-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relieves Vaginal Dryness
Use
·Provides temporary relief from Intimate dryness and discomfort.
·Moisturizes and soothes the Intimate area.
Warnings
1.For lntimate use only,not for oral use.
2.The product should not be used as a substitute for medicines and medical devices.
Do Not Use
Do not use if you are pregnant,during menstruation, or breastfeeding.
When Using
lf this is the first time you are experiencing vaginal dryness or discomfort. consult your healthcare provider.
Stop Use
·you experience abdominal pain,fever, chills,nausea.vomiting, of foul-smelling discharge.
·symptoms worsen or do not improve within 7 days.
Ask Doctor
·you experience abdominal pain.fever, chills, nausea, vomiting or foul-smelling discharge.
·symptoms worsen or do not improve within 7 days.
Keep Out Of Reach Of Children
This product is for adult use only.
Directions
·Dispense 2 pumps of cream onto clean fingers. ·Smooth over the inner lips and perineum.(Not for internal use).
·Apply once or twice a day, apply at bedtime while lying down.
·Wait 20 minutes for the cream to be fully absorbed.
Other Information
Store in a dry and cool place at 20°C-25°C(68°F-77°F).
Inactive Ingredients
Purified Water, Vegetable Glycerin,Aloe Vera Gel, Caprylic/Capric,Triglyceride, Stearic Acid, Olive Oil, Coconut Oil,Shea Butter,Sunflower Lecithin, Methylsulfonylmethane (MSM),Stearyl Alcohol, Isopropyl Palmitate, Allantoin, Carbomer,
Sodium Bicarbonate, Herbal-Active(Natural Preservative)
Principal Display Panel
0.1 (D2f6094727f4760b6a2a8ebfa338dede)
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