Label: ADVANCED FORMULA PROGESTO-LIFE- progesterone cream

  • 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.

View All Sections
  • Active Ingredient

    Progesterone

  • Purpose

    This is a topical cream that contains micronized, USP Progesterone. 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 Progesterone. 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 inner wrists or abdomen twice per day 3 weeks of the month or as recommended by your physician.

  • Inactive Ingredients

    Deionized Water, Caprylic Capric Triglyceride, Shea Butter, Stearic Acid, Cetyl Alcohol, Glycerin, Tocopheryl Acetate, Sodium Hydroxymethylglycinate, Potassium Sorbate

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED FORMULA PROGESTO-LIFE 
    progesterone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82653-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE16.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82653-004-01150 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!