SPL v1
SPL
SPL Set ID 3c77f787-b7dd-6813-e063-6394a90aa004
Route
EXTRACORPOREAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.eta.-tocopherol (1 mL) Butyrospermum Parkii (shea) Oil (1 g)
Inactive Ingredients
Cucumber Coconut Avocado Fruit Water Gluconolactone Theobroma Grandiflorum Fruit Radish Aloe Barbadensis Leaf

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

STEP 1: Dispense 2 pumps STEP 2: Apply on the inner lips and perineum before bed STEP 3: Wait 20 mins for absorption


Medication Information

Recent Major Changes

For external use only, Keep out of reach of children.Avoid contact with eyes.

Warnings and Precautions



Not evaluated by FDA. Not intended to diagnose/treat any disease

Indications and Usage



STEP 1: Dispense 2 pumps

STEP 2: Apply on the inner lips and perineum before bed

STEP 3: Wait 20 mins for absorption

Dosage and Administration

50G/1.76OZ

Description

STEP 1: Dispense 2 pumps STEP 2: Apply on the inner lips and perineum before bed STEP 3: Wait 20 mins for absorption

Section 42232-9



For external use only. Avoid direct contact with eyes. If the product gets into your eyes, rinse immediately with plenty of water. Ensure skin is not broken or severely irritated before use. If any discomfort or allergic reaction occurs, discontinue useimmediately and consult a doctor. TIP: For optimal results, maintain daily use and increase frequency as needed based on personal requirements. Keep out of reach of children. Keep in a dry and cool place. For all skin types

Section 50565-1



Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right

away

Section 51727-6



WATER

THEOBROMA GRANDIFLORUM EXTRACT

RADISH EXTRACT

ALOE BARBADENSIS

COCONUT EXTRACT

CUCUMBER EXTRACT

Section 51945-4

Section 55105-1



Soothes & Hydrates: Delivers long-lasting moisture to ease intimate dryness and discomfort.

Section 55106-9

TOAC-1%

BUTYROSPERMUM PARKII-1%

Section 59845-8



✔️External Intimate Dryness: For discomfort, tightness, or mild irritation in the vulvar area caused by dryness.

✔️Pre/Post Certain Activities: To enhance comfort before intimacy or soothe dryness after activities like swimming, exercise, or shaving.


Structured Label Content

Recent Major Changes (34066-1)

For external use only, Keep out of reach of children.Avoid contact with eyes.

Indications and Usage (34067-9)



STEP 1: Dispense 2 pumps

STEP 2: Apply on the inner lips and perineum before bed

STEP 3: Wait 20 mins for absorption

Dosage and Administration (34068-7)

50G/1.76OZ

Warnings and Precautions (34071-1)



Not evaluated by FDA. Not intended to diagnose/treat any disease

Section 42232-9 (42232-9)



For external use only. Avoid direct contact with eyes. If the product gets into your eyes, rinse immediately with plenty of water. Ensure skin is not broken or severely irritated before use. If any discomfort or allergic reaction occurs, discontinue useimmediately and consult a doctor. TIP: For optimal results, maintain daily use and increase frequency as needed based on personal requirements. Keep out of reach of children. Keep in a dry and cool place. For all skin types

Section 50565-1 (50565-1)



Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right

away

Section 51727-6 (51727-6)



WATER

THEOBROMA GRANDIFLORUM EXTRACT

RADISH EXTRACT

ALOE BARBADENSIS

COCONUT EXTRACT

CUCUMBER EXTRACT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Soothes & Hydrates: Delivers long-lasting moisture to ease intimate dryness and discomfort.

Section 55106-9 (55106-9)

TOAC-1%

BUTYROSPERMUM PARKII-1%

Section 59845-8 (59845-8)



✔️External Intimate Dryness: For discomfort, tightness, or mild irritation in the vulvar area caused by dryness.

✔️Pre/Post Certain Activities: To enhance comfort before intimacy or soothe dryness after activities like swimming, exercise, or shaving.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)