Olivia Quido Acne Cream

Olivia Quido Acne Cream
SPL v1
SPL
SPL Set ID 2051f52c-c52b-749d-e063-6394a90a7815
Route
TOPICAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Carthamus Tinctorius (safflower) Oleosomes Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Polyacrylamide (10000 Mw) Water Peg-100 Stearate Magnesium Sulfate, Unspecified Potassium Cetyl Phosphate 1,2-hexanediol Dimethicone Glyceryl Monostearate Ppg-12/smdi Copolymer Hexyl Laurate Hyaluronate Sodium Silicon Dioxide Titanium Dioxide Glycerin Laureth-7 Potassium Sorbate Tetrahexyldecyl Ascorbate C13-14 Isoparaffin Alkyl (c12-15) Benzoate Alpha-tocopherol Acetate Polyglyceryl-4 Isostearate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-23

Description

Benzoyl Peroxide 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.



• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.



• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.



• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Dosage and Administration

Directions



• Clean the skin thoroughly before applying this product



• Cover the entire affected area with a thin layer one to three times daily

Description

Benzoyl Peroxide 5%

Uses

For the treatment of acne

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if irritation becomes severe

Section 50567-7

• Skin irritation and dryness will likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.



• Avoid urinecessary sun exposure and use a sunscreen.



• Avoid contact with the eyes, lips, and mouth.



• Avoid contact with hair and dyed fabrics, which may be bleached by this product.



• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.



Irritation may be reduced by using the product less frequently or in a lower concentration.

Keep out of eyes. Rinse with water to remove.

Section 50570-1

• Have very sensitive skin



• Are sensitive to Benzoyl Peroxide

Section 51727-6

Inactive Ingredients



1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dipotassium Glycyrrhizate, Glycerin, Glyceryl Stearate, Hexyl Laurate, Laureth-7, Lecithin, Magnesium Sulfate, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-4 Isostearate, Potassium Cetyl Phosphate, Potassium Sorbate, PPG-12/SMDI Copolymer, Silica, Sodium Acrylates Copolymer, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Benzoyl Peroxide 5%

Section 60561-8

Other Information



• Protect from excessive heat and direct sunlight



• Store at controlled temperature: 15°C -30°C (59°F-86°F)


Structured Label Content

Uses

For the treatment of acne

Indications and Usage (34067-9)

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.



• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.



• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.



• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Dosage and Administration (34068-7)

Directions



• Clean the skin thoroughly before applying this product



• Cover the entire affected area with a thin layer one to three times daily

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation becomes severe

Section 50567-7 (50567-7)

• Skin irritation and dryness will likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.



• Avoid urinecessary sun exposure and use a sunscreen.



• Avoid contact with the eyes, lips, and mouth.



• Avoid contact with hair and dyed fabrics, which may be bleached by this product.



• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.



Irritation may be reduced by using the product less frequently or in a lower concentration.

Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

• Have very sensitive skin



• Are sensitive to Benzoyl Peroxide

Section 51727-6 (51727-6)

Inactive Ingredients



1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dipotassium Glycyrrhizate, Glycerin, Glyceryl Stearate, Hexyl Laurate, Laureth-7, Lecithin, Magnesium Sulfate, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-4 Isostearate, Potassium Cetyl Phosphate, Potassium Sorbate, PPG-12/SMDI Copolymer, Silica, Sodium Acrylates Copolymer, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Benzoyl Peroxide 5%

Section 60561-8 (60561-8)

Other Information



• Protect from excessive heat and direct sunlight



• Store at controlled temperature: 15°C -30°C (59°F-86°F)


Advanced Ingredient Data


Raw Label Data

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