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 US LLC, Baxter Laboratories Pty. Ltd.. 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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor:

• If skin irritation becomes severe

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.

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.

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: 73122-126
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
MANDELIC ACID (UNII: NH496X0UJX)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ALLANTOIN (UNII: 344S277G0Z)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENYLPROPANOL (UNII: 0F897O3O4M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CLOVE OIL (UNII: 578389D6D0)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
DIMETHICONE (UNII: 92RU3N3Y1O)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
WATER (UNII: 059QF0KO0R)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
ARGININE (UNII: 94ZLA3W45F)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-126-01	50 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(73122-126)