AMER FRESH- benzalkonium chloride soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial For washing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

AMER FRESH- 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._
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ACTIVE INGREDIENT
Benzalkonium Chloride 0.1%
PURPOS E
Antibacterial
US E
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
AMER FRESH
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:8 0 8 6 5-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .1 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM PALMITATE (UNII: JQ43KP6 29 6 )
PALM KERNEL O IL (UNII: B0 S9 0 M0 233)
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
EDETATE SO DIUM (UNII: MP1J8 420 LU)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:8 0 8 6 5-0 0 1-0 1
10 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
11/10 /20 20
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 rt333A
11/10 /20 20
LABELER -
MRJ'S CRO