ADVANCED FORMULA PROGESTO-LIFE- progesterone cream

Advanced Formula Progesto-Life by

Drug Labeling and Warnings

Advanced Formula Progesto-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

Progesterone

Purpose

When applied to the skin, it may help with appearance

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

INGREDIENTS AND APPEARANCE

ADVANCED FORMULA PROGESTO-LIFE 
progesterone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82653-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	16.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82653-004-01	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2022
2	NDC: 82653-004-02	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/19/2025

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)