Label: ESTRO-LIFE- estriol cream

  • NDC Code(s): 82653-001-01, 82653-001-02
  • Packager: Smoky Mountain Naturals, LLC - DBA SMNutrition
  • 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.

Drug Label Information

Updated March 31, 2022

If you are a consumer or patient please visit this version.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    ESTRO-LIFE 
    estriol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82653-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL1.69 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82653-001-01100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2022
    2NDC:82653-001-02150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2022
    Labeler - Smoky Mountain Naturals, LLC - DBA SMNutrition (098382607)