ULTRA CLEAR FOAMING CLEANSER- salicylic acid lotion

Ultra Clear Foaming Cleanser by

Drug Labeling and Warnings

Ultra Clear Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by ULTRACEUTICALS PTY LIMITED. 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

When using this product:

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water to remove.

If irritation occurs, only use one topical medication

INDICATIONS & USAGE

Stop use and ask a doctor:

if skin irritation becomes severe

WARNINGS

Warnings

For External use only.

• 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.

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 Ingredients

Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betaine, 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

150mL / 5.07 fl. Oz.

INGREDIENTS AND APPEARANCE

ULTRA CLEAR FOAMING CLEANSER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-050
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
CLOVE OIL (UNII: 578389D6D0)
PHENYLPROPANOL (UNII: 0F897O3O4M)
NIACINAMIDE (UNII: 25X51I8RD4)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
LACTIC ACID (UNII: 33X04XA5AT)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALLANTOIN (UNII: 344S277G0Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MANDELIC ACID (UNII: NH496X0UJX)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-050-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2019
2	NDC: 10028-050-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/11/2019

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty Ltd		740537709	manufacture(10028-050)