Label: ESTRIOL 5.0 CREAM- estriol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82018-0010-4 - Packager: SHYNE BRANDS
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated June 21, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
USES:
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.
DIRECTIONS:
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.
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WARNINGS
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESTRIOL 5.0 CREAM
estriol creamProduct 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)
