CLEANSING WIPES- salicylic acid swab 
Nextcell Medical

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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Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

Keep out of reach of children

 If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Alpha-Glucan Oligosaccharide, Amylopectin, Bioflavonoids, Brassica Oleracea, Italica (Broccoli) Extract, Capryloyl Glycine, Caprylyl Glycol, Cinnamomum Zeylanicum Barck Extract, Cocoamidopropyl PG-Dimonium, Chloride Phosphate, Decyl Glucoside, Dextrin, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Water, Hexylene Glycol, Niacinamide, Phenoxyethanol, Polydextrose, Propanediol, Sarcosine, Water

Cleansing Wipe Label

CLEANSING WIPES 
salicylic acid swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71613-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
witch hazel (UNII: 101I4J0U34)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
Polydextrose (UNII: VH2XOU12IE)  
AMYLOPECTIN (UNII: 4XO4QFV777)  
Niacinamide (UNII: 25X51I8RD4)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
SARCOSINE (UNII: Z711V88R5F)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
ALCOHOL (UNII: 3K9958V90M)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71613-001-0125 in 1 POUCH07/28/2017
13 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/28/2017
Labeler - Nextcell Medical (060650171)
Registrant - Nextcell Medical (060650171)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes International, Inc.161104729manufacture(71613-001)

Revised: 7/2017
Document Id: 7239c6fd-f68a-4f74-ad7c-368f90e3cb4f
Set id: e0ad155f-8afb-42ba-a2c3-c10f27561201
Version: 1
Effective Time: 20170728
 
Nextcell Medical