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.

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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

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

Other information

Store below 110F

Inactive ingredients

Fragrance, purified water, vegetable glycerin

Package Label - Principal Display Panel

59 mL NDC: 80038-003-01

2oz Italian Lemon Lime label

236 mL NDC: 80038-003-02

8oz Italian Lemon Lime label

946 mL NDC: 80038-003-03

32oz Italian Lemon Lime label

HAND SANITIZER - ITALIAN LEMON AND LIME 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80038-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.72 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80038-003-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2020
2NDC:80038-003-02236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2020
3NDC:80038-003-03946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/06/2020
Labeler - Phenom Marketing Group, Inc. (046354714)
Establishment
NameAddressID/FEIBusiness Operations
Phenom Marketing Group, Inc.046354714manufacture(80038-003)

Revised: 2/2022
Document Id: d6fb2f20-d5c8-3025-e053-2a95a90a7839
Set id: b107f1cf-6a55-2228-e053-2995a90a9ac5
Version: 2
Effective Time: 20220201
 
Phenom Marketing Group, Inc.