ULTRA CLEAR TREATMENT- salicylic acid lotion

Ultra Clear Treatment by

Drug Labeling and Warnings

Ultra Clear Treatment 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 2% w/w Acne Treatment

PURPOSE

Uses

For treatment of acne
Helps clear acne blemishes and acne pimples

INDICATIONS & USAGE

Stop use and ask a doctor:

If skin irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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 dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients

Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.

PRINCIPAL DISPLAY PANEL

Ultraceuticals

Ultra Clear Treatment Lotion

with Salicylic & Mandelic Acid

Acne Treatment Lotion

50mL / 1.69 fl OZ

INGREDIENTS AND APPEARANCE

ULTRA CLEAR TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-051
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
BENTONITE (UNII: A3N5ZCN45C)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
WATER (UNII: 059QF0KO0R)
CLOVE OIL (UNII: 578389D6D0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
ARGININE (UNII: 94ZLA3W45F)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MANDELIC ACID (UNII: NH496X0UJX)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-051-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/15/2019

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(10028-051)