Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f388310c-dfd9-b9b5-e053-2a95a90ab22d
Route
TOPICAL
Published
Effective Date 2023-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Linalool, (+/-)- (0.0123856248 g) .beta.-citronellol, (r)- (0.0072288108 g) Geraniol (0.003659868 g) Limonene, (+/-)- (0.0330317226 g)
Inactive Ingredients
Olive Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-01-15

Description

citronellol, geraniol, linalool, limonene


Medication Information

Warnings and Precautions

This product is for exeternal use only. Do not use for internal use

Storage and handling precautions

If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse

Avoid placing the product near fire and store out in reach of children

- consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

- do not use on wounded area

Indications and Usage

take an appropriate amount of this product and spread evenly on the skin

Dosage and Administration

for external use only

Description

citronellol, geraniol, linalool, limonene

Section 50565-1

keep out or reach of the children

Section 51727-6

Olea Europaea (Olive) Fruit Oil

Carthamus Tinctorius (Safflower) Seed Oil

Helianthus Annuus (Sunflower) Seed Oil

Camellia Japonica Seed Oil

Macadamia Integrifolia Seed Oil

Tocopheryl Acetate

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Pelargonium Graveolens Flower Oil

Cananga Odorata Flower Oil

Cedrus Atlantica Bark Oil

Lavandula Angustifolia (Lavender) Oil

Rosa Damascena Flower Oil

Tocopherol

Copaifera Officinalis (Balsam Copaiba) Resin

Jasminum Officinale (Jasmine) Oil

Citrus Aurantium Dulcis (Orange) Oil

Artemisia Absinthium Extract

Citrus Grandis (Grapefruit) Peel Oil

Myrtus Communis Oil

Rose Flower Oil

Vanilla Planifolia Fruit Extract

Ferula Galbaniflua (Galbanum) Resin Oil

Section 51945-4

Section 55105-1

intensive treatment body cream

Section 55106-9

citronellol, geraniol, linalool, limonene


Structured Label Content

Indications and Usage (34067-9)

take an appropriate amount of this product and spread evenly on the skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

This product is for exeternal use only. Do not use for internal use

Storage and handling precautions

If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse

Avoid placing the product near fire and store out in reach of children

- consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

- do not use on wounded area

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Olea Europaea (Olive) Fruit Oil

Carthamus Tinctorius (Safflower) Seed Oil

Helianthus Annuus (Sunflower) Seed Oil

Camellia Japonica Seed Oil

Macadamia Integrifolia Seed Oil

Tocopheryl Acetate

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Pelargonium Graveolens Flower Oil

Cananga Odorata Flower Oil

Cedrus Atlantica Bark Oil

Lavandula Angustifolia (Lavender) Oil

Rosa Damascena Flower Oil

Tocopherol

Copaifera Officinalis (Balsam Copaiba) Resin

Jasminum Officinale (Jasmine) Oil

Citrus Aurantium Dulcis (Orange) Oil

Artemisia Absinthium Extract

Citrus Grandis (Grapefruit) Peel Oil

Myrtus Communis Oil

Rose Flower Oil

Vanilla Planifolia Fruit Extract

Ferula Galbaniflua (Galbanum) Resin Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

intensive treatment body cream

Section 55106-9 (55106-9)

citronellol, geraniol, linalool, limonene


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)