Label: ESTRIOL 5.0 CREAM- estriol cream
- NDC Code(s): 82018-0010-4
- Packager: SHYNE BRANDS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated June 21, 2021
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- ACTIVE INGREDIENT
INDICATIONS & USAGE
This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.
Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.
For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement:
This product contains estrogen, a chemical known only to the state of California to cause cancer.
KEEP OUT OF REACH OF CHILDREN.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ESTRIOL 5.0 CREAM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82018-0010 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL 5 mg in 85 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) 1 mg in 85 g ALLANTOIN (UNII: 344S277G0Z) 1 mg in 85 g LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 1 mg in 85 g SHEA BUTTER (UNII: K49155WL9Y) 1 mg in 85 g COCONUT OIL (UNII: Q9L0O73W7L) 1 mg in 85 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mg in 85 g OLIVE OIL (UNII: 6UYK2W1W1E) 1 mg in 85 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) 1 mg in 85 g ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1 mg in 85 g GLYCERIN (UNII: PDC6A3C0OX) 1 mg in 85 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82018-0010-4 85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2021 Labeler - SHYNE BRANDS (014926486)