ULTRA CLEAR FOAMING CLEANSER ACNE- salicylic acid lotion

Ultra Clear Foaming Cleanser Acne by

Drug Labeling and Warnings

Ultra Clear Foaming Cleanser Acne by is a Otc medication manufactured, distributed, or labeled by Ultraceuticals US, LLC, Baxter Laboratories Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Salicylic Acid 0.5% w/w Acne Treatment

PURPOSE

Uses

• For treatment of ACne
• Clear acne blemishes

KEEP OUT OF REACH OF CHILDREN

For external use only

INDICATIONS & USAGE

Stop use and ask a doctor:

• if skin irritation becomes severe

WARNINGS

Warnings

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 m

DOSAGE & ADMINISTRATION

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer and rinse thoroughly 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 dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

Inactive Ingredient

Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betain, Sodium Hydroxide, Mandelic Acid, Caprylyl Glycol, Sodium Lauroyl Lactylate, Allantoin, Sodium Chloride, Sodium PCA, Disodium EDTA, Phenylpropanol, Niacinamide, Disodium Lauriminodipropionate Tocopheryl Phosphates, Eucalyptus Globulus Leaf Oil, Fusanus Spicatus Wood Oil, Eugenia Caryophyllus (Clove) Bud Oil, Sodium Benzoate, Benzoic acid, Phenoxyethanol, Dehydroacetic Acid.

PRINCIPAL DISPLAY PANEL

Ultraceuticals

Ultra Clear Foaming Cleanser

with Mandelic & Salicylic Acid

Acne Face Cleanser

INGREDIENTS AND APPEARANCE

ULTRA CLEAR FOAMING CLEANSER ACNE 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73122-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
LACTIC ACID (UNII: 33X04XA5AT)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MANDELIC ACID (UNII: NH496X0UJX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-125-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/26/2019

Labeler - Ultraceuticals US, LLC (117022448)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty Ltd		740537709	manufacture(73122-125)