AROMA GURU ANTIBACTERIAL ITALIAN CITRUS- hand soap liquid

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
31-08-2022

active_ingredient:

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

MAH:

GURUNANDA LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Antibacterial Stop Use and ask Doctor if irritation or redness develops For hand washing to decrease bacteria on the skin

authorization_status:

OTC monograph not final

SPC

                                AROMA GURU ANTIBACTERIAL ITALIAN CITRUS- HAND SOAP LIQUID
GURUNANDA LLC
_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._
----------
ANTIBACTERIAL HAND SOAP ITALIAN CITRUS
Benzalkonium Chloride 0.13%
Antibacterial
For External Use Only
When using this product- Avoid contact with eyes. In case of eye
contact, flush with
water.
Stop Use and ask Doctor if irritation or redness develops
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away.
Pump in hands , wet as needed- Lather vigorously for at least 15
seconds- Wash skin
thoroughly and dry.
Store below 110° F (43° C)
Water, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG 150
Distearate,
Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid,
Methylisothiazolinone,
ldopropynyl Butylcarbamate, FD& C Yellow No. 5
For hand washing to decrease bacteria on the skin
AROMA GURU ANTIBACTERIAL ITALIAN CITRUS
GURUNANDA LLC
hand soap liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70708-099
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.13 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
8 g in 100 g
WATER (UNII: 059QF0KO0R)
85.37 g in 100 g
PRODUCT CHARACTERISTICS
COLOR
yellow
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70708-
099-01
399.6 g in 1 BOTTLE, PUMP; Type 0: Not a
Combination Product
12/03/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
12/03/2020
LABELER -
GURUNANDA LLC (079671169)
Revised: 8/2022
                                
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