Germ Out Antibacterial Wet Wipes

Germ Out Antibacterial Wet Wipes by

Drug Labeling and Warnings

Germ Out Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by Flex Beauty Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GERM OUT ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
Flex Beauty Labs LLC

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Germ Out Antibacterial Wet Wipes

DRUG FACTS

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

To reduce bacteria on the skin.

Warnings

For external use only.

DO NOT USE

if you are allergic to any of the ingredients.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor 

if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 2 years of age: Apply to hands, Allow to dry without wiping. Children under 2 years of age: ask doctor prior to use.

Other information:

Store below 110°F(43°C). May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water (Aqua), Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Fragrance (Parfum), Ethylhexylglycerin, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Extract, Tetrasodium EDTA, Citric Acid.

Package Labeling:20ct

Package Labeling:60ct

GERM OUT ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72308-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72308-025-20	20 in 1 PACKET	08/15/2020	09/30/2022
1		3.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 72308-025-60	60 in 1 PACKET	08/15/2020	12/31/2022
2		3.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/15/2020	12/31/2022

Labeler - Flex Beauty Labs LLC (080858917)

Establishment
Name	Address	ID/FEI	Business Operations
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi		565657236	manufacture(72308-025)

Revised: 6/2024

Document Id: 19ffa58c-a48e-cb7a-e063-6394a90a2074

34390-5

Set id: 14840d2e-7137-48b5-b2f2-6c50d41fcb4d

Version: 4

Effective Time: 20240603