ACNE DEFENSE SPOT TREATMENT MERLE NORMAN- salicylic acid gel 
Merle Norman Cosmetics, Inc

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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Acne Defense Spot Treatment

Active Ingredient:                             Purpose

Salicylic Acid 2.0%                             Acne Treatment

For the treatment of Acne

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away

Using other topical acne medication at the same tim or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

Cleanse skin thoroughly before applying. Cover the entire affected area with a thing layer 1 to 3 times daily or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

SD Alcohol 40-B, Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Polyacrylate Crosspolymer 6, Laminaria Saccarina Extract, Thermus Thermophillus Ferment, Opuntia Ficus-Indica Stem Extract, Sea Whip Extract, Bisabolol, Glycerin, Pentylene Glycol, Butylene Glycol, Propylene Glycol, Aminomethyl Propanol, 4-t-Butylcyclohexanol, Hydroxyethylcellulose, Hydroxymethoxyphenyl Decanone, Benzalkonium Chloride

ACNE DEFENSE

SPOT TREATMENT

ACNE TREATMENT GEL   

merle norman

14g e

NET WT. .50 OZ.

label

carton

ACNE DEFENSE SPOT TREATMENT  MERLE NORMAN
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
LEVOMENOL (UNII: 24WE03BX2T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-201-021 in 1 CARTON07/14/2017
1NDC:57627-201-0114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/14/2017
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc008479388manufacture(57627-201)

Revised: 1/2020
Document Id: e8b66c88-8d30-4d21-ac61-118ac3d38ddf
Set id: c6296d3a-fabe-4a8f-91e8-cac2ae6ff926
Version: 3
Effective Time: 20200127
 
Merle Norman Cosmetics, Inc