ESTRIOL 5.0 CREAM- estriol cream

Estriol 5.0 Cream by

Drug Labeling and Warnings

Estriol 5.0 Cream by is a Otc medication manufactured, distributed, or labeled by SHYNE BRANDS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredients

Micronizrd Estriol USP (Wild Yam) .5%

PURPOSE

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

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.

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

If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

DOSAGE & ADMINISTRATION

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 you physician.

INACTIVE INGREDIENT

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)

QUESTIONS

Questions?

care@biolabspro.com

www.biolabspro.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESTRIOL 5.0 CREAM 
estriol 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)