ANTI ACNE EXFOLIATING CLEANSING PADS - salicylic acid swab 
H2O Plus

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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Drug Facts

Active ingredient
Salicylic Acid 1%

Purpose
Acne Treatment

Warnings
For external use only.
Flammable - Keep away from open fire or flame.

Ask a doctor or pharmacist before use if you
are using other topical acne medications at the
same time or immediately following use of this
product. This may increase dryness or irritation
of the skin. If this occurs, only one medication
should be used unless directed by a doctor.

Use for the treatment of acne.

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

Directions After cleansing, sweep pad
gently over face and neck.

Inactive ingredients
Water, SD Alcohol 39-C, Hamamelis Virginiana (Witch
Hazel) Bark/Leaf/Twig Extract, Sodium Lactate,
PPG-5-Ceteth-20, PEG-12 Dimethicone, Fragrance
(Parfum), Linalool, Allantoin, Butylene Glycol, Lysine
Carboxymethyl Cysteinate, Propylene Glycol, Menthol,
Poterium Officinale Extract, Cinnamomum Cassia
Bark Extract, Zingiber Officinale (Ginger) Root Extract,
Palmaria Palmata Extract, Crithmum Maritimum
Extract, Himanthalia Elongata Extract, Gigartina
Stellata Extract, Macrocystis Pyrifera Extract, Sea
Salt (Maris Sal), Blue 1 (CI 42090), Yellow 5 (CI 19140)

Image of label aaep242.jpg
Image of label
ANTI ACNE EXFOLIATING CLEANSING PADS 
salicylic acid swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHOL (UNII: L7T10EIP3A)  
SANGUISORBA MINOR ROOT (UNII: 11YGU8I0TT)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
GINGER (UNII: C5529G5JPQ)  
DULSE (UNII: 7832HOY4ZQ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
MASTOCARPUS STELLATUS (UNII: 6T087FC66H)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
SEA SALT (UNII: 87GE52P74G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-242-0157 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2008
Labeler - H2O Plus (807722947)
Registrant - H2O Plus (807722947)
Establishment
NameAddressID/FEIBusiness Operations
H2O Plus807722947manufacture

Revised: 9/2011
Document Id: 60b452e3-2135-45de-a1fa-18c5141a64d2
Set id: de384124-cdb9-4d6b-ae4d-351214182c58
Version: 1
Effective Time: 20110928
 
H2O Plus