DERMAFOAM PREMIUM ANTIBACTERIAL- benzalkonium chloride soap

DermaFoam Premium Antibacterial by

Drug Labeling and Warnings

DermaFoam Premium Antibacterial by is a Otc medication manufactured, distributed, or labeled by Superior Chemical Corporation, Betco corporation, Ltd., Betco Corporation, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredient

​ ​Triclosan 0.30%

INDICATIONS & USAGE

Uses

• ​​Antibacterial hand cleaner.
• Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

WARNINGS

Warnings

• For external use only.
• Avoid contact with eyes.
• Children under the age of 6 should be supervised by an adult when using this product.
• Discontinue use is irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.
• KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

Directions

• ​Read the entire label before using this product.
• ​Dispense 0.8 mL of product onto wet palm.
• Rub hands together to distribute product, then rinse hands with clean.

INACTIVE INGREDIENT

Inactive Ingredients

​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

QUESTIONS

Questions or Comments?Phone: (800) 777-9343

MDS information:​(800) 891-4965

PURPOSE

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

75129-00_Derma Foam Premium Antibacterial

INGREDIENTS AND APPEARANCE

DERMAFOAM PREMIUM ANTIBACTERIAL 
benzalkonium chloride soap

Product 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
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CITRAL (UNII: T7EU0O9VPP)
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)
GERANIOL (UNII: L837108USY)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL (UNII: 1DR20642YH)
4-CYCLOHEXYL-2-METHYL-2-BUTANOL (UNII: HFL24LW6V5)
LINALOOL (UNII: D81QY6I88E)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
2,6-DIMETHYLOCTAN-2-OL (UNII: EKV1VX27WR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53125-709-39	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/12/2012

Labeler - Superior Chemical Corporation (023335086)

Registrant - Betco corporation, Ltd. (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		005050158	label(53125-709) , manufacture(53125-709)