SPL v2
SPL
SPL Set ID 2f305967-207b-6da9-e063-6294a90a571c
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Beeswax (0.2 g) Grape Seed Oil (5 g) Shea Butter (2 g)
Inactive Ingredients
Matricaria Chamomilla Flowering Top Oil Sunflower Seed Honey Evening Primrose Oil Emu Oil Tocopherol Hydrogenated Coconut Oil Hydrogenated Avocado Oil Aqua Royal Jelly Rosa Rugosa Flower Centella Asiatica Polygonum Cuspidatum Root Scutellaria Baicalensis Root Rosemary Artemisia Scoparia Whole Olive Oil Laminaria Digitata

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

50g(1.76oz)


Medication Information

Warnings and Precautions



1. For Extemal Use Only. 2. Avoid Direct Contact with Eyes. 3. If the product

gets into your eyes, rinse immediately with plenty of water. 4. Ensure skin is

not broken or severely irritated before use. 5. If any discomfort or allergic

reaction occurs, discontinue use immediately and consult a doctor.6. TIP

For optimal results, maintain daily use and increase frequency as needed

based on personal requirements. 7. Keep Out of Reach of Children.

Indications and Usage

Clean Hands: Ensure your hands are clean and dry.

Apply Directly: Apply an appropriate amount of the productectly.

Massage to Absorb:Gently massage until fully absorbed.

Dosage and Administration

50g(1.76oz)

Description

50g(1.76oz)

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

AQUA

SUNFLOWER SEED OIL

MEL

OLIVE FRUIT OIL

EVENING PRIMROSE OIL

EMU OIL

TOCOPHEROL

HYDROGENATED COCONUT OIL

HYDROGENATED AVOCADO OIL

HIPPOPHAE RHAMNOIDES OIL

ROYAL JELLY EXTRACT

ROSA RUGOSA FLOWER EXTRACT

CENTELLA ASIATICA EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ARTEMISIA SCOPARIA EXTRACT

Section 51945-4

Section 55105-1

Address dryness, discomfort, and sensitivity in delicate areas.


Structured Label Content

Indications and Usage (34067-9)

Clean Hands: Ensure your hands are clean and dry.

Apply Directly: Apply an appropriate amount of the productectly.

Massage to Absorb:Gently massage until fully absorbed.

Dosage and Administration (34068-7)

50g(1.76oz)

Warnings and Precautions (34071-1)



1. For Extemal Use Only. 2. Avoid Direct Contact with Eyes. 3. If the product

gets into your eyes, rinse immediately with plenty of water. 4. Ensure skin is

not broken or severely irritated before use. 5. If any discomfort or allergic

reaction occurs, discontinue use immediately and consult a doctor.6. TIP

For optimal results, maintain daily use and increase frequency as needed

based on personal requirements. 7. Keep Out of Reach of Children.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

AQUA

SUNFLOWER SEED OIL

MEL

OLIVE FRUIT OIL

EVENING PRIMROSE OIL

EMU OIL

TOCOPHEROL

HYDROGENATED COCONUT OIL

HYDROGENATED AVOCADO OIL

HIPPOPHAE RHAMNOIDES OIL

ROYAL JELLY EXTRACT

ROSA RUGOSA FLOWER EXTRACT

CENTELLA ASIATICA EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ARTEMISIA SCOPARIA EXTRACT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Address dryness, discomfort, and sensitivity in delicate areas.


Advanced Ingredient Data


Raw Label Data

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