GERMS BE GONE ANTIBACTERIAL NON SCENTED- antiseptic hand cream cream

Germs Be Gone Antibacterial by

Drug Labeling and Warnings

Germs Be Gone Antibacterial by is a Otc medication manufactured, distributed, or labeled by BRANDS INTERNATIONAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds

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 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

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

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

Directions

• Rub thoroughly on hands for at least 30 seconds and allow to dry
• Supervise children when using this product to avoid swallowing.
• Adults and children over 2 years
• For occasional and domestic use

Other information

• Store between 15-30C (59-86F)
• May discolor certain fabrics or surfaces

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

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

GERMS BE GONE ANTIBACTERIAL  NON SCENTED
antiseptic hand cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-523-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/14/2021

Labeler - BRANDS INTERNATIONAL CORPORATION (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
BRANDS INTERNATIONAL CORPORATION		243748238	manufacture(50157-523)