ACNEFREE DERMATOLOGY INSPIRED CARE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide kit

AcneFree Dermatology Inspired Care Sensitive Skin 24 Hr Acne Clearing System by

Drug Labeling and Warnings

AcneFree Dermatology Inspired Care Sensitive Skin 24 Hr Acne Clearing System by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Universal Packaging Systems, Inc. (DBA: PakLab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Sensitive Skin Acne Lotion

Drug Facts

Active ingredient

Benzoyl peroxide 3%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• skin irritation and dryness is more liekly to 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 unnecessary 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 irritaiton 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.

Stop use and ask a doctor if

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• 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 producs and ask a doctor.

Other information

Store at 60°-95° F (15°-35° C)

Inactive Ingredients

Water, Ethyl Macadamiate, Propanediol, Glycerin, Butylene Glycol, Polyacrylamide, Phenoxyethanol, C13-14 Isoparaffin, Bisabolol, Laureth-7, Allantoin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Sodium Hyaluronate, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Hydroxide, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract

Questions or comments?

1-888-768-2913

Salicylic Acid Acne Cleanser

Drug Facts

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• if bothersome dryness or peeling occurs, reduce application use
• may be used on chest or back

Other information

store at 60°-95° F (15°-35° C)

Inactive Ingredients

Water, Sodium Cocoyl Isethionate, Stearic Acid, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Disodium Laureth Sulfosuccinate, Glycol Distearate, Polyacrylate-1 Crosspolymer, Benzyl Alcohol, Avena Sativa (Oat) Kernel Extract, Sodium Phytate, Zinc PCA, Glycerin, Sorbic Acid, Ethyl Vanillin, Butylene Glycol, Sea Whip Extract, Aminomethyl Propanol

Questions or comments?

1-888-768-2913

Fruit Enzyme Toner

Directions

Use every morning and evening. After cleansing, apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest or back.

Ingredients

Water, Niacinamide, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Extract, Sea Whip Extract, Saccharum Officinarum (Sugar Cane) Extract, Zingiber Officinale (Ginger) Root Extract, Pentylene Glycol, Benzyl Alcohol, Isoceteth-20, Aminomethyl Propanol, Salicylic Acid, Disodium EDTA, Bisabolol, Benzalkonium Chloride, Glycerin, Sorbic Acid, Butylene Glycol

Questions or comments?

1-888-768-2913

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNEFREE DERMATOLOGY INSPIRED CARE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-034

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-034-01	1 in 1 CARTON	08/24/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	59 mL
Part 2	1 TUBE	118 mL

Part 1 of 2

ACNEFREE DERMATOLOGY INSPIRED CARE SENSITIVE SKIN ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LEVOMENOL (UNII: 24WE03BX2T)
LAURETH-7 (UNII: Z95S6G8201)
ALLANTOIN (UNII: 344S277G0Z)
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D

Part 2 of 2

ACNEFREE DERMATOLOGY INSPIRED CARE ACNE CLEANSER 
salicylic acid liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHYTATE SODIUM (UNII: 88496G1ERL)
ZINC PIDOLATE (UNII: C32PQ86DH4)
GLYCERIN (UNII: PDC6A3C0OX)
SORBIC ACID (UNII: X045WJ989B)
ETHYL VANILLIN (UNII: YC9ST449YJ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/24/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. (DBA: PakLab)		790530976	MANUFACTURE(49967-034)