SPL v1
SPL
SPL Set ID 25311dfa-a447-700f-e063-6394a90ae1da
Route
CUTANEOUS
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (45 g)
Inactive Ingredients
Ethylhexyl Palmitate Bisabolol Parfumidine Allantoin Cetyl Ethylhexanoate Isohexadecane Cetearyl Behenate Squalane

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-09

Description

MINERAL OIL


Medication Information

Warnings and Precautions

Risk InformationFor external use only

Mention de risquesPour usage externe seulement

Do not use on damaged or broken skin.

Ne pas utiliser sur la peau endommagée ou avec des lésions

If rash occurs, discontinue use and consult a health care practitioner.

En présence d'une éruption cutanée, cesser l'utilisation et consulter un praticien de soins de santé

When using this product keep out of eyes. Rinse with water to remove.

Eviter tout contact avec les yeux. Rincer a l'eau le cas échéant

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

Tenir hors de portée des enfants

En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.

Indications and Usage

Temporarily protects and helps relieve dry or cracked skin

Beneficlal for face, hands, body, and legs

Dosage and Administration

Apply once daily to clean face and neck, avoiding the eye area

Description

MINERAL OIL

Section 50565-1

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

Tenir hors de portée des enfants

En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.

Section 50567-7

Avoid contact with eyes and broken skin. If redness, swelling, or irritation occurs, discontinue use immediately and seek medical advice.

Section 51727-6

MINERAL OIL

ETHYLHEXYL PALMITATE

BISABOLOL

PARFUM

CETYL ETHYLHEXANOATE

ISOHEXADECANE

ANTHEMIS NOBILIS FLOWER OILLAVANDULA ANGUSTIFOLIA (LAVENDER) OILVALERIANA OFFICINALIS ROOT OIL虑CITRUS AURANTIUM AMARA (BITTER ORANGE) LEAFJASMINUM SAMBAC UASMINE) FLOWER OIL

SQUALANE

OLEA EUROPAEA (OLIVE) FRUIT OILTOCOPHERYL ACETATESIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

CI 15850

Section 51945-4

Section 55105-1

After cleansing andtoning, take an appropriate amount ofthis product and apply it evenly on theface, massage until absorbed

Section 55106-9

MINERAL OIL

Ask Doctor

If you have a history of skin allergies or have sensitive skin, it is advisable to consult a doctor before using this product.


Structured Label Content

Indications and Usage (34067-9)

Temporarily protects and helps relieve dry or cracked skin

Beneficlal for face, hands, body, and legs

Dosage and Administration (34068-7)

Apply once daily to clean face and neck, avoiding the eye area

Warnings and Precautions (34071-1)

Risk InformationFor external use only

Mention de risquesPour usage externe seulement

Do not use on damaged or broken skin.

Ne pas utiliser sur la peau endommagée ou avec des lésions

If rash occurs, discontinue use and consult a health care practitioner.

En présence d'une éruption cutanée, cesser l'utilisation et consulter un praticien de soins de santé

When using this product keep out of eyes. Rinse with water to remove.

Eviter tout contact avec les yeux. Rincer a l'eau le cas échéant

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

Tenir hors de portée des enfants

En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.

Section 50565-1 (50565-1)

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

Tenir hors de portée des enfants

En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.

Section 50567-7 (50567-7)

Avoid contact with eyes and broken skin. If redness, swelling, or irritation occurs, discontinue use immediately and seek medical advice.

Section 51727-6 (51727-6)

MINERAL OIL

ETHYLHEXYL PALMITATE

BISABOLOL

PARFUM

CETYL ETHYLHEXANOATE

ISOHEXADECANE

ANTHEMIS NOBILIS FLOWER OILLAVANDULA ANGUSTIFOLIA (LAVENDER) OILVALERIANA OFFICINALIS ROOT OIL虑CITRUS AURANTIUM AMARA (BITTER ORANGE) LEAFJASMINUM SAMBAC UASMINE) FLOWER OIL

SQUALANE

OLEA EUROPAEA (OLIVE) FRUIT OILTOCOPHERYL ACETATESIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

CI 15850

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

After cleansing andtoning, take an appropriate amount ofthis product and apply it evenly on theface, massage until absorbed

Section 55106-9 (55106-9)

MINERAL OIL

Ask Doctor

If you have a history of skin allergies or have sensitive skin, it is advisable to consult a doctor before using this product.


Advanced Ingredient Data


Raw Label Data

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