CLARIFYING BACNE- salicylic acid spray

Clarifying Bacne by

Drug Labeling and Warnings

Clarifying Bacne by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., Bell International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid (1.0%)

Purpose

Acne Treatment

Uses

For the treatment of acne

Warnings

For external use only

Do not use

• In or near eyes. If contact occurs, flush thoroughly with water.
• If irritation develops, discontinue use.

When using this product

• 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.
• Do not inhale.

Keep out of reach of children.

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

Contents under pressure

• Do not puncture or incinerate can.
• Do not store at temperatures above 120°F.

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.
• Hold the spray about a foot and a half away from your body and mist onto clean, dry skin.
• Let it sink into skin for 30-60 seconds.

Inactive ingredients

Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Oil, Citrus Reticulata (Tangerine) Leaf Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Butylene Glycol, Tocopherol, Beta-Sitosterol, Ethylhexylglycerin, Polysorbate 20, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Benzoic Acid, Limonene, Linalool, Citral, Geraniol, Citronellol, Coumarin.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

clarifying
bacne spray

clears + rebalances

dermalogica
clear start

6 US FL OZ / 177 mL ℮

INGREDIENTS AND APPEARANCE

CLARIFYING BACNE 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-782
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
Isoceteth-20 (UNII: O020065R7Z)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
Hexylene Glycol (UNII: KEH0A3F75J)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
Sodium Hydroxide (UNII: 55X04QC32I)
TEA TREE OIL (UNII: VIF565UC2G)
Ethylhexylglycerin (UNII: 147D247K3P)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Butylene Glycol (UNII: 3XUS85K0RA)
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)
Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO)
ARGAN OIL (UNII: 4V59G5UW9X)
Benzoic Acid (UNII: 8SKN0B0MIM)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
SESAME OIL (UNII: QX10HYY4QV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
Tocopherol (UNII: R0ZB2556P8)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SAW PALMETTO (UNII: J7WWH9M8QS)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
Geraniol (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
Coumarin (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-782-02	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	10/01/2023

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International		967781555	MANUFACTURE(68479-782)