Label: ANTI ACNE CLARIFYING FACE WASH- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 65903-247-01 - Packager: H2O Plus
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated September 28, 2011
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient
Salicylic Acid 1.5%...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 dailyWhen 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.
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) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI ACNE CLARIFYING FACE WASH
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65903-247 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 15 uL in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65903-247-01 118 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358B 04/01/2009 Labeler - H2O Plus (807722947) Registrant - H2O Plus (807722947) Establishment Name Address ID/FEI Business Operations H2O Plus 807722947 manufacture