Otc - Active Ingredient
DRUG FACTS
Active Ingredients (per 1g):
Estriol .032%
Dhea .668%
Natural Revita Vaginal Moisturizer
FDA Label NDC 82018-0025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shyne Brands/biolabs Pro for the product Natural Revita Vaginal Moisturizer (NDC 82018-0025). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Natural Vaginal Moisturizer for women with bioidentical Estriol and Dhea.
Indications & Usage
Uses
Helps relieve symptoms of vulvovaginal atrophy due to menopause, including vaginal dryness, itching, and discomfort.
Warnings
Warnings
For external use only. Do not use if pregnant, nursing, or trying to conceive. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.If irritation or rash develops, discontinue use and consult a healthcare provider.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children.
Dosage & Administration
Directions
Apply 1 dose (3 pumps) to the internal and external vulvar area 2-3 days a week, or as directed by your healtchare professional.
Inactive Ingredient
Inactive Ingredients
Shea Butter', Sunflower Oil, Almond Oil, Cocoa Butter·, Beeswax, Vitamin E, and Hyaluronic Acid.
·certified Organic.
Otc - Questions
Questions?
[email protected]
www.biolabspro.com
Package Label.Principal Display Panel
Revita Drug Facts Label (Revitadrugfactslabel)
* Please review the disclaimer below.
