Safe and Soft Antibacterial Hand Wipes Fresh Scent

Safe and Soft Antibacterial Hand Wipes Fresh Scent by

Drug Labeling and Warnings

Safe and Soft Antibacterial Hand Wipes Fresh Scent by is a Otc medication manufactured, distributed, or labeled by D.P.L. DISPOSABLE PRODUCTS INDUSTRIES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE AND SOFT ANTIBACTERIAL HAND WIPES FRESH SCENT- benzalkonium chloride cloth 
D.P.L. DISPOSABLE PRODUCTS INDUSTRIES LIMITED

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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Safe and Soft Antibacterial Hand Wipes Fresh Scent

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

Hand sanitizer to reduce bacteria on the skin.

Warnings

For external use only-hands

When using this product

• Do not use in or near eyes
• In case of contact with eyes, flush thoroughly with water
• Avoid contact with broken skin

Stop use and ask a doctor

if skin Irritation develops

Keep out of reach of children.

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

Directions

• wipe hands thoroughly with product and allow to dry
• for children under 6, use only under adult supervision
• not recommended for infants

Inactive ingredients

water, polysorbate 20, glycerin, phenoxyethanol, aloe (aloe barbadensis) leaf juice, fragrance, methylparaben, tocopheryl acetate, tetrasodium EDTA, disodium cocoamphodiacetate, butylparaben, citric acid, ethylparaben, propylparaben

Package Labeling:72 wipes

Package Labeling:25 wipes

SAFE AND SOFT ANTIBACTERIAL HAND WIPES FRESH SCENT 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42425-300
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42425-300-72	72 in 1 PACKAGE	07/15/2020	12/31/2021
1		3.6 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 42425-300-25	25 in 1 PACKAGE	07/15/2020	12/31/2021
2		5.76 mL 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 not final	part333E	07/15/2020	12/31/2021

Labeler - D.P.L. DISPOSABLE PRODUCTS INDUSTRIES LIMITED (600712814)

Revised: 3/2022

Document Id: d9d20d19-0c8f-db98-e053-2995a90a84c2

34390-5

Set id: b60b5b0d-9ee9-77c1-e053-2995a90ad449

Version: 2

Effective Time: 20220309

 

D.P.L