84735-014 Estriol Cream

84735-014 Estriol Cream
SPL v4
SPL
SPL Set ID 3a81e44d-004e-e69f-e063-6394a90a5d35
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estradiol (0.02 g) Estriol (2 g)
Inactive Ingredients
Lecithin, Sunflower Shea Butter Carbomer Coconut Oil Dimethyl Sulfone Allantoin Glycerin Olive Oil Aloe Vera Leaf Isopropyl Palmitate Stearyl Alcohol Sodium Benzoate Water Potassium Sorbate Caprylic/capric Triglyceride Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-22

Description

Estriol Estradiol


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps support hormonal balance. Mayhelp ease symptoms associated with menopause

Dosage and Administration

Massage into the inner arm, thighs, orchest, or apply to the inner forearmand rub arms together until absorbedApply two pumps in the morning andtwo in the afternoon or evening, or asdirected by a healthcare provider.

Description

Estriol Estradiol

Section 50565-1



Keep out of reachof children.

lf swallowed, get medicalhelp or contact a Poison Control Centerimmediately

Section 50567-7



Avoid contact with eyes.lfcontact occurs, rinse thoroughly withwater.

lf rritation or rash develops,discontinue use and consultahealthcare provider.

Section 50570-1

Do not use ifpregnant, nursing, or trying toconceive.

Section 51727-6

Purified Water

Vegetable Glycerin

Aloe Vera Leaf Gel

Caprylic/Capric Triglyceride

Stearic Acid

Olive Oil

Coconut Oil

Shea Butter

Sunflower Lecithin

Methylsulfonylmethane (MSM)

Stearyl Alcohol

Isopropyl Palmitate

Allantoin

Carbomer

Sodium Benzoate

Potassium Sorbate

Section 51945-4

Section 55105-1

Hormone support

Section 55106-9

Estriol

Estradiol


Structured Label Content

Indications and Usage (34067-9)

Helps support hormonal balance. Mayhelp ease symptoms associated with menopause

Dosage and Administration (34068-7)

Massage into the inner arm, thighs, orchest, or apply to the inner forearmand rub arms together until absorbedApply two pumps in the morning andtwo in the afternoon or evening, or asdirected by a healthcare provider.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)



Keep out of reachof children.

lf swallowed, get medicalhelp or contact a Poison Control Centerimmediately

Section 50567-7 (50567-7)



Avoid contact with eyes.lfcontact occurs, rinse thoroughly withwater.

lf rritation or rash develops,discontinue use and consultahealthcare provider.

Section 50570-1 (50570-1)

Do not use ifpregnant, nursing, or trying toconceive.

Section 51727-6 (51727-6)

Purified Water

Vegetable Glycerin

Aloe Vera Leaf Gel

Caprylic/Capric Triglyceride

Stearic Acid

Olive Oil

Coconut Oil

Shea Butter

Sunflower Lecithin

Methylsulfonylmethane (MSM)

Stearyl Alcohol

Isopropyl Palmitate

Allantoin

Carbomer

Sodium Benzoate

Potassium Sorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hormone support

Section 55106-9 (55106-9)

Estriol

Estradiol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)