ANTI ACNE CLARIFYING FACE WASH - salicylic acid gel 
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.

----------

DRUG FACTS

Active Ingredient
Salicylic Acid 1.5%...

Purpose
acne treatment

For external use only

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 skin. If this occurs, only
one medication should be used unless directed by a doctor.


Wash affected area twice daily

When using this product avoid contact with eyes.
If contact occurs, rinse thoroughly with water.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away. If
excessive skin irritation develops or increases, discontinue
use and consult a doctor.

Directions

Wash affected area twice daily

Questions? call 1-800-242-2284 M-F, 8am-6pm CST

Water (Aqua), Sodium C14-16 Olefin Sulfonate,
Cocamidopropyl Betaine, Glycerin, Sodium Chloride,
Linoleamidopropyl PG-Dimonium Chloride Phosphate,
Fragrance (Parfum), Disodium EDTA, Butylene Glycol,
Aloe Barbadensis Leaf Juice, Menthol, Propylene
Glycol, Poterium Officinale Root 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, Blue 1 (CI 42090)

Image of label aacf247.jpg
Image of label
ANTI ACNE CLARIFYING FACE WASH 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-247
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid15 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
GINGER (UNII: C5529G5JPQ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
MASTOCARPUS STELLATUS (UNII: 6T087FC66H)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-247-01118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B04/01/2009
Labeler - H2O Plus (807722947)
Registrant - H2O Plus (807722947)
Establishment
NameAddressID/FEIBusiness Operations
H2O Plus807722947manufacture

Revised: 9/2011
Document Id: 66d51ead-8eae-43d5-98a8-cde6ab9ac918
Set id: 3e8f57ef-21e3-4771-aa99-2a15547b352f
Version: 1
Effective Time: 20110928
 
H2O Plus