HOME FORMATION ANTIBACTERIAL COCONUT AND HIBISCUS- benzalkonium chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

PATCOS COSMETICS (INDIA) PRIVATE LIMITED

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial For hand washing to decrease bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HOME FORMATION ANTIBACTERIAL COCONUT AND HIBISCUS- BENZALKONIUM
CHLORIDE LIQUID
PATCOS COSMETICS (INDIA) PRIVATE LIMITED
_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._
----------
ACTIVE INGREDIENT
Benzalkonium Chloride (0.13%)
PURPOS E
Antibacterial
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT avoid contact with eyes. In case of eyes
contact, flush with water.
STOP USE AND ASK A DOCTOR IF irritation and redness develops.
KEEP OUT OF REACH OF CHILDREN if swallowed, get medical help or
contact a Poison control center right
away.
US ES
For hand washing to decrease bacteria on the skin.
DIRECTIONS
• Pump into hands.
• Lather vigorously for at least 15 seconds.
• Rinse and dry thoroughly.
INACTIVE INGREDIENT
Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol
Distearate & Cocamide MEA &
Laureth - 10, Cocamido Propyl Betaine,
Cocomonoethanolamide, Sodium Chloride, Glycerine, Perfume, PEG 150
Distearate, Bronopol,
Disodium EDTA, Phenoxyethanol, Benzophenone 3, Citric Acid, FD & C Red
40,CI. No. 16035.
LABEL
HOME FORMATION ANTIBACTERIAL COCONUT AND HIBISCUS
benzalkonium chloride liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 121-0 0 3
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 g
in 10 0 mL
PATCOS COSMETICS (INDIA) PRIVATE LIMITED
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)
PEG-150 DISTEARATE (UNII: 6 F36 Q0 I0 AC)
BRO NO PO L (UNII: 6 PU1E16 C9 W)
EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)
PHENO XYETHANO L (UNII: