ESTRO-LIFE- estriol cream

Estro-Life by

Drug Labeling and Warnings

Estro-Life by is a Otc medication manufactured, distributed, or labeled by Smoky Mountain Naturals, LLC - DBA SMNutrition. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Estriol

Purpose

This is a topical cream that contains micronized, USP estriol. When applied to the skin it may help support the body’s balance of hormones.

Uses

This is a topical cream that contains micronized, USP estriol. When applied to the skin it may help support the body’s balance of hormones. 

Warnings

*These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Consult your healthcare provider before using this product especially if you are pregnant, nursing, intend to get pregnant, taking medication, or have a medical condition. This product does not treat, cure, or prevent menopause. If irritation occurs, discontinue use. For external use only. Do not use around eye area. Do not apply this cream internally. Double check the ingredients list for known allergies before using this cream.

Keep out of the reach of children. Do not use if safety seal is missing or broken. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN

Directions

Apply 1/4 tsp to thin skin, inner wrist, or abdomen daily or as recommended by your physician.

Inactive Ingredients

Deionized Water, Propylene Glycol, Sorbitol, Glyceryl Stearate, Stearic Acid, Dimethicone, Steareth-2, Steareth-20, Retinyl Palmitate, Tocopheryl Acetate, Methylparaben, Propylparaben.

Product label

INGREDIENTS AND APPEARANCE

ESTRO-LIFE 
estriol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82653-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E)	ESTRIOL	1.69 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82653-001-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2022
2	NDC: 82653-001-02	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2022

Labeler - Smoky Mountain Naturals, LLC - DBA SMNutrition (098382607)