SPL v1
SPL
SPL Set ID 2530ff3c-0b82-2c53-e063-6294a90a06fa
Route
CUTANEOUS
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Kaolin (37.5 g)
Inactive Ingredients
Diglycerin Mineral Oil Cetearyl Alcohol Polysorbate 60 Glyceryl Stearate Se Peg-100 Stearate Sorbitan Stearate Water

Identifiers & Packaging

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

Description

KAOLIN


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

KAOLIN

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

GLYCERIN

MINERAL OIL

CETEARYL ALCOHOL

POLYSORBATE 60

WATER

GLYCERYL STEARATE

PEG-100 STEARATE

SORBITAN STEARATE

WATER

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

LAURETH-7

WATER

XANTHAN GUM

PHENOXYETHANOL

ALLANTOIN

DIAZOLIDINYL UREA

WATER

METHYLPARABEN

C177266

WATER

PROPYLENE GLYCOL

PHENOXYETHANOL

CAPRYLYL GLYCOL

FRAGRANCE

WATER

BUTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

PHENOXYETHANOL

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

KAOLIN

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)

GLYCERIN

MINERAL OIL

CETEARYL ALCOHOL

POLYSORBATE 60

WATER

GLYCERYL STEARATE

PEG-100 STEARATE

SORBITAN STEARATE

WATER

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

LAURETH-7

WATER

XANTHAN GUM

PHENOXYETHANOL

ALLANTOIN

DIAZOLIDINYL UREA

WATER

METHYLPARABEN

C177266

WATER

PROPYLENE GLYCOL

PHENOXYETHANOL

CAPRYLYL GLYCOL

FRAGRANCE

WATER

BUTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

PHENOXYETHANOL

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)

KAOLIN

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.


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Raw Label Data

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