GERMS BE GONE ANTIBACTERIAL SCENTED- antiseptic hand cream cream 
BRANDS INTERNATIONAL CORPORATION

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.

----------

Germs Be Gone Antibacterial Hand Sanitizing cream- Scented

Active Ingredient(s)

Benzalkonium chloride 0.05 %.

Purpose

Antiseptic skin cleanser

Use

To help reduce bacteria on hands.

Warnings

For external use only.

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. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

Aqua (Water), Propylene Glycol, Isopropyl Myristate, Isopropyl Palmitate, Stearyl Alcohol, Ceteareth-20, Glycerin, Glyceryl Stearate,
Caprylic/Capric Triglyceride, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera Oil (Coconut),
Petroleum Jelly, Vitamin E (Tocopherol), DMDM Hydantoin, Allantoin, Aloe Barbadensis Leaf Extract, Perfume

Package Label - Principal Display Panel

4

GERMS BE GONE ANTIBACTERIAL  SCENTED
antiseptic hand cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-524
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRICAPRYLIN (UNII: 6P92858988)  
ALLANTOIN (UNII: 344S277G0Z)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-524-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product08/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/14/2021
Labeler - BRANDS INTERNATIONAL CORPORATION (243748238)
Establishment
NameAddressID/FEIBusiness Operations
BRANDS INTERNATIONAL CORPORATION243748238manufacture(50157-524)

Revised: 8/2021
Document Id: c99088df-b1a9-0d93-e053-2995a90af4a5
Set id: c99088df-b1a8-0d93-e053-2995a90af4a5
Version: 2
Effective Time: 20210814
 
BRANDS INTERNATIONAL CORPORATION