ULTRA CLEAR FOAMING CLEANSER ACNE- salicylic acid lotion 
Ultraceuticals US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ultra Clear Foaming Cleanser
Acne Face Cleanser

Active Ingredients Purpose

Salicylic Acid 0.5% w/w Acne Treatment

Uses

For external use only

Stop use and ask a doctor:

Warnings

When using this product:

Directions

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.

Ultraceuticals

Ultra Clear Foaming Cleanser

with Mandelic & Salicylic Acid

Acne Face Cleanser

Clear foaming carton

ULTRA CLEAR FOAMING CLEANSER ACNE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-125-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/26/2019
Labeler - Ultraceuticals US, LLC (117022448)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Laboratories Pty Ltd740537709manufacture(73122-125)

Revised: 9/2019
Document Id: 93684625-59d0-2542-e053-2995a90ac4cb
Set id: 93684625-59cf-2542-e053-2995a90ac4cb
Version: 1
Effective Time: 20190925
 
Ultraceuticals US, LLC