IT COSMETICS BYE BYE BREAKOUT CONCENTRATED DERMA SERUM ACNE TREATMENT- salicylic acid lotion

IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment by

Drug Labeling and Warnings

IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc., Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Use

• for the treatment of acne
• helps prevent new acne blemishes from forming

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

• 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 ingrease to two or three times dialy if neded or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other dayl

Inactive ingredients

water, glycerin, niacinamide, lactic acid, sodium hydroxide, zinc PCA, aloe barbadensis leaf juice, butylene glycol, chlorphenesin, sodium hyaluronate, trisodium ethylenediamine disuccinate, alteromonas ferment extract, citric acid, potassium sorbate, sodium benzoate

Questions or comments?

Call 800-620-3950

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS BYE BYE BREAKOUT CONCENTRATED DERMA SERUM ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ZINC PIDOLATE (UNII: C32PQ86DH4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-026-01	1 in 1 CARTON	04/01/2022
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 49967-026-02	4 mL in 1 PACKET; Type 0: Not a Combination Product	04/01/2022	04/01/2022
3	NDC: 49967-026-03	4 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2022
4	NDC: 49967-026-04	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/01/2022

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-026) , pack(49967-026)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	pack(49967-026)