Label: DERMAFOAM PREMIUM ANTIBACTERIAL- benzalkonium chloride soap
- NDC Code(s): 53125-709-29
- Packager: Superior Chemical
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 29, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DermaFoam Premium Antibacterial Active Ingredients
- DermaFoam Premium Antibacterial Indications
-
DermaFoam Premium Antibacterial
Warnings
Warnings
- For external use only.
- Avoid contact with eyes.
- If contact occurs, rinse thoroughly with water.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
- If swallowed, get medical help or contact a Poison Control Center right away.
- DermaFoam Premium Antibacterial Dosage
-
DermaFoam Premium Antibacterial
Inactive Ingredients
Inactive Ingredients
Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.
- DermaFoam Premium Antibacterial Purpose
- DermaFoam Premium Antibacterial Keep our of Reach of Children
- DermaFoam Premium Antibacterial
-
INGREDIENTS AND APPEARANCE
DERMAFOAM PREMIUM ANTIBACTERIAL
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53125-709 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 1 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MAGNESIUM NITRATE (UNII: 77CBG3UN78) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) GERANIOL (UNII: L837108USY) 2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL (UNII: 1DR20642YH) ALLYL HEPTANOATE (UNII: AU4CYG9V68) CITRAL (UNII: T7EU0O9VPP) LIMONENE, (+)- (UNII: GFD7C86Q1W) 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) LINALOOL, (+/-)- (UNII: D81QY6I88E) DIHYDROMYRCENOL (UNII: 46L1B02ND9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53125-709-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 07/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/19/2017 Labeler - Superior Chemical (023335086) Registrant - Betco Corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(53125-709) , label(53125-709)
