AROMA GURU ANTIBACTERIAL ITALIAN CITRUS- hand soap liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
GURUNANDA LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization number:
70708-099-01

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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.

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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

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)

Registrant -

GURUNANDA LLC (079671169)

Establishment

Name

Address

ID/FEI

Business Operations

GURUNANDA LLC

079671169

repack(70708-099)

GURUNANDA LLC

Revised: 6/2021

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