ESTRIOL 5.0 CREAM- estriol cream 
SHYNE BRANDS

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.

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Estriol 5.0 Cream

DRUG FACTS

Active Ingredients

Micronizrd Estriol USP (Wild Yam) .5%

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

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.

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.

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.

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.

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?

care@biolabspro.com

www.biolabspro.com

Estriol Label

ESTRIOL 5.0 CREAM 
estriol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82018-0010
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL5 mg  in 85 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82018-0010-485 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2021
Labeler - SHYNE BRANDS (014926486)

Revised: 6/2021
Document Id: c54ecf47-cc1b-85e8-e053-2995a90aef0e
Set id: c4d3d276-f78e-17c1-e053-2995a90a590d
Version: 3
Effective Time: 20210621
 
SHYNE BRANDS