BREAKOUT CLEARING BOOSTER- salicylic acid liquid

BREAKOUT CLEARING BOOSTER by

Drug Labeling and Warnings

BREAKOUT CLEARING BOOSTER by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Salicylic Acid (2.0%)

Purpose

Acne Treatment

Use

• For the treatment of acne

Warnings

For external use only

Do not use

• In or near eyes. If contact occurs, flush thoroughly with water.

When using this product

• Apply to affected areas only.
• Skin irritation and dryness are 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 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.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, PPG-15 Stearyl Ether, Butylene Glycol, Glycerin, Isopropyl Lauroyl Sarcosinate, Niacinamide, Cetearyl Glucoside, 1,2-Hexanediol, Polysorbate 20, Hydroxyacetophenone, Chlorella Vulgaris Extract, Terpineol, Thymol, Chondrus Crispus (Carrageenan) Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Lactic Acid, Sodium Hyaluronate, Dimethicone, Xanthan Gum, Sclerotium Gum, Lecithin, Pullulan, Propanediol, Tetrasodium Glutamate Diacetate, Silica, Sodium Hydroxide, Sodium Citrate, Limonene.

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

clears breakout
causing bacteria in
15 minutes

breakout clearing
booster

dermatologica
clear start

1.0 US FL OZ / 30 mL e

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING BOOSTER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-772
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)
Niacinamide (UNII: 25X51I8RD4)
Cetearyl Glucoside (UNII: 09FUA47KNA)
1,2-Hexanediol (UNII: TR046Y3K1G)
Polysorbate 20 (UNII: 7T1F30V5YH)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
Dimethicone (UNII: 92RU3N3Y1O)
Xanthan Gum (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Propanediol (UNII: 5965N8W85T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Pullulan (UNII: 8ZQ0AYU1TT)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
Terpineol (UNII: R53Q4ZWC99)
Thymol (UNII: 3J50XA376E)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Sodium Hydroxide (UNII: 55X04QC32I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-772-02	1 in 1 CARTON	04/09/2021
1		30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2	NDC: 68479-772-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2021
3	NDC: 68479-772-05	4 mL in 1 TUBE; Type 0: Not a Combination Product	04/09/2021
4	NDC: 68479-772-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	04/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	04/09/2021

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		052400223	MANUFACTURE(68479-772)