DERMAFOAM PREMIUM ANTIBACTERIAL- benzalkonium chloride soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Superior Chemical
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - ​ ​Antibacterial skin cleanser. - Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices. Purpose Antibacterial
Authorization status:
OTC monograph not final
Authorization number:
53125-709-29

DERMAFOAM PREMIUM ANTIBACTERIAL- benzalkonium chloride soap

Superior Chemical

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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DermaFoam Premium Antibacterial

DermaFoam Premium Antibacterial

Active Ingredients

Active Ingredient

Benzalkonium Chloride 0.13%

DermaFoam Premium Antibacterial

Indications

Uses

Antibacterial skin cleanser.

Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians

offices.

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

Dos age

Directions

Read the entire label before using this product.

Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both

hands.

Rinse with clean water.

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

Purpos e

Purpose

Antibacterial

DermaFoam Premium Antibacterial

Keep our of Reach of Children

KEEP OUT OF REACH OF CHILDREN

DermaFoam Premium Antibacterial

75129-00_Derma Foam Premium Antibacterial.jpg

DERMAFOAM PREMIUM ANTIBACTERIAL

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53125-70 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYLAMINE O XIDE (UNII: M4SL8 2J7HK)

N-ALKYL DIMETHYL BENZYL AMMO NIUM CHLO RIDE ( C12 -C18 ) (UNII: 9 U1Q4T4ZYS)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)

MAGNESIUM NITRATE (UNII: 77CBG3UN78 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GERANIO L (UNII: L8 3710 8 USY)

2 -TERT-BUTYLCYCLO HEXYLO XYBUTANO L (UNII: 1DR20 6 42YH)

ALLYL HEPTANO ATE (UNII: AU4CYG9 V6 8 )

CITRAL (UNII: T7EU0 O9 VPP)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

2 -TERT-BUTYLCYCLO HEXYL ACETATE (UNII: 36 4FV6 0 9 13)

TETRASO DIUM GLUTAMATE DIACETATE (UNII: 5EHL50 I4MY)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

DIHYDRO MYRCENO L (UNII: 46 L1B0 2ND9 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53125-70 9 -29

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 7/19 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 7/19 /20 17

Labeler -

Superior Chemical (023335086)

Registrant -

Betco Corporation, Ltd. (024492831)

Superior Chemical

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Betco Co rpo ratio n, Ltd.

0 2449 28 31

manufacture(53125-70 9 ) , label(53125-70 9 )

Revised: 7/2020

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