AMERFRESH ANTIBACTERIAL UNWRAPPED- benzalkonium chloride soap

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

Toedieningsweg:

TOPICAL

Prescription-type:

OTC DRUG

therapeutische indicaties:

Antibacterial For washing to decrease bacteria on the skin

Autorisatie-status:

OTC monograph not final

Productkenmerken

AMERFRESH ANTIBACTERIAL UNWRAPPED- BENZALKONIUM CHLORIDE SOAP
MRJ'S CROWN INDUSTRIES 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 0.1%
PURPOSE
Antibacterial
USE
For washing to decrease bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT avoid contact with eyes .in case of eyes
contact ,flush with
water
STOP USE AND DOCTOR ASK IF irritation and redness develops
KEEP OUT OF REACH OF CHILDREN if swallowed ,get medical help or
contact a Poison
control center right away .
DIRECTIONS
• Wet bar with water
• Lather vigorously and wash skin
• Rinse and dry thoroughly
INACTIVE INGREDIENTS
• Sodium Palmitate
• Palm Kernelate
• Fragrance
• Aqua
• Sodium Chloride
• Glycerine
• Titanium Di Oxide
• Tetra Sodium EDTA
PRODUCT LABEL
AMERFRESH ANTIBACTERIAL UNWRAPPED
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:80865-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.068 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM PALMITATE (UNII: JQ43KP6296)
PALM KERNEL OIL (UNII: B0S90M0233)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE SODIUM (UNII: MP1J8420LU)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:80865-002-
01
200 in 1 CARTON
11/19/2020
1
10 in 1 PACKAGE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
APPLICATION NUMBER OR MONOGRAPH
MARKETING START
MARKETING END
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED
CATEGORY
CITATION
DATE
DATE
OTC monograph not
final
part333A
11/19/2020
LABELER -
MRJ'S CROWN INDUST