SPL v1
SPL
SPL Set ID 215a0fdc-6178-acd0-e063-6294a90ad4d2
Route
TOPICAL
Published
Effective Date 2024-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Portulaca Oleracea Seed (10.5 g) Black Olive (7.5 g) Menthol, Unspecified Form (12.5 g) Orange (4.5 g) Shea Butter
Inactive Ingredients
Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-05

Description

CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPAEA (OLIVE) FRUITIEXTRACT, MENTHOL, PORTULACA OLERACEA SEED EXTRACT

Purpose

Improve the phenomenon of varicose veins


Medication Information

Purpose

Improve the phenomenon of varicose veins

Description

CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPAEA (OLIVE) FRUITIEXTRACT, MENTHOL, PORTULACA OLERACEA SEED EXTRACT

Use

1.Wash skin with warm water.2.Use this product approprlately 2 to 4 times a day.3.Rub gently on the affected area for one minute and absorbdthe cream in the morning and evening.

Section 44425-7

Avoid freezing and excessive heat above 40C (104F) )

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 51727-6

ALLANTOIN

Section 51945-4

Stop Use

Discontinue use if signs of irritation or rash occur.

Warnings

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do Not Use

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPAEA (OLIVE) FRUITIEXTRACT, MENTHOL, PORTULACA OLERACEA SEED EXTRACT


Structured Label Content

Use

1.Wash skin with warm water.2.Use this product approprlately 2 to 4 times a day.3.Rub gently on the affected area for one minute and absorbdthe cream in the morning and evening.

Section 44425-7 (44425-7)

Avoid freezing and excessive heat above 40C (104F) )

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 51727-6 (51727-6)

ALLANTOIN

Section 51945-4 (51945-4)

Purpose

Improve the phenomenon of varicose veins

Stop Use (STOP USE)

Discontinue use if signs of irritation or rash occur.

Warnings

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do Not Use (Do not use)

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPAEA (OLIVE) FRUITIEXTRACT, MENTHOL, PORTULACA OLERACEA SEED EXTRACT


Advanced Ingredient Data


Raw Label Data

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