Label: ADVANCED FORMULA ESTRO-LIFE- estriol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82653-002-01, 82653-002-02 - 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.
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- Active Ingredient
- Purpose
- Uses
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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
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
ADVANCED FORMULA ESTRO-LIFE
estriol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82653-002 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82653-002-01 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2022 2 NDC:82653-002-02 150 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)