ADVANCED FORMULA PROGESTO-LIFE- progesterone cream 
Smoky Mountain Naturals, LLC - DBA SMNutrition

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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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.

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

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)

Revised: 3/2022
Document Id: db873562-99ea-06da-e053-2995a90a8523
Set id: 5de7b13c-7db6-4d03-9792-9edc3c6ca78a
Version: 1
Effective Time: 20220331
 
Smoky Mountain Naturals, LLC - DBA SMNutrition