HAND SANITIZER - ITALIAN LEMON AND LIME- alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Phenom Marketing Group, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Antimicrobial Hand Sanitizer to help reduce bacteria on the skin - On children under 2 months - On broken skin Stop use and ask a doctor if irritation or rash occurs and persists

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER - ITALIAN LEMON AND LIME- ALCOHOL LIQUID
PHENOM MARKETING GROUP, INC.
_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(S)
Alcohol 85% v/v. Purpose: Antiseptic
Benzalkonium Chloride 0.1%. Purpose: Antimicrobial
PURPOSE
Antiseptic, Antimicrobial
USE
Hand Sanitizer to help reduce bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME
DO NOT USE
On children under 2 months
On broken skin
WHEN USING THIS PRODUCT keep out of eyes, ears, and mouth. In case of
contact with
eyes, rinse eyes thoroughly with water.
STOP USE AND ASK A DOCTOR if irritation or rash occurs and persists
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help
DIRECTIONS
Spray product on hands to cover all surfaces
Rub hands together until dry
Supervise children under 6 years
OTHER INFORMATION
Store below 110F
INACTIVE INGREDIENTS
Fragrance, purified water, vegetable glycerin
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
59 mL NDC: 80038-003-01
236 mL NDC: 80038-003-02
946 mL NDC: 80038-003-03
HAND SANITIZER - ITALIAN LEMON AND LIME
alcohol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:80038-003
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.1 g
in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
85 mL
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
0.72 mL in 100 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:80038-
003-01
59 mL in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
10/06/2020
Phenom Marketing Group, Inc.
2
NDC:80038-
003-02
236 mL in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Produ