HAND SANITIZER - ITALIAN LEMON AND LIME- alcohol liquid

Hand Sanitizer - Italian Lemon and Lime by

Drug Labeling and Warnings

Hand Sanitizer - Italian Lemon and Lime by is a Otc medication manufactured, distributed, or labeled by Phenom Marketing Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs and persists

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

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)	BENZALKONIUM 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
2	NDC: 80038-003-02	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/06/2020
3	NDC: 80038-003-03	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/06/2020

Labeler - Phenom Marketing Group, Inc. (046354714)

Establishment
Name	Address	ID/FEI	Business Operations
Phenom Marketing Group, Inc.		046354714	manufacture(80038-003)