OLIVIA QUIDO ACNE CREAM- benzoyl peroxide cream

Olivia Quido Acne Cream by

Drug Labeling and Warnings

Olivia Quido Acne Cream by is a Otc medication manufactured, distributed, or labeled by O Skin Care LLC, KDC/ONE SOCAL LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 5%

PURPOSE

Acne Treatment

Uses

For the treatment of acne

WARNINGS

For external use only

DO NOT USE

Have very sensitive skin

Are sensitive to Benzoyl Peroxide

WHEN USING

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.

STOP USE

Stop use and ask a doctor if irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Clean the skin thoroughly before applying this product

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

INDICATIONS & 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.

OTHER SAFETY INFORMATION

Other Information

Protect from excessive heat and direct sunlight

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OLIVIA QUIDO ACNE CREAM 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71421-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-7 (UNII: Z95S6G8201)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71421-902-04	60 g in 1 TUBE; Type 0: Not a Combination Product	08/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/23/2024

Labeler - O Skin Care LLC (021275401)

Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE SOCAL LABORATORIES, LLC		118384240	manufacture(71421-902)