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NDC 23957-0085-00 Safe and Soft Antibacterial Hand Wipes 15 Count 1.3 mg/mL Details

Safe and Soft Antibacterial Hand Wipes 15 Count 1.3 mg/mL

Safe and Soft Antibacterial Hand Wipes 15 Count is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Albaad USA, Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	23957-0085
Product ID	23957-085_a2394251-a24d-d2c0-e053-2995a90a681c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Safe and Soft Antibacterial Hand Wipes 15 Count
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Albaad USA, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 23957-0085-00 (23957008500)

Pricing Information	N/A
NDC Package Code	23957-085-00
Billing NDC	23957008500
Package	15 PATCH in 1 CARTON (23957-085-00) / 5 mL in 1 PATCH
Marketing Start Date	2020-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a2394351-e2a2-0106-e053-2995a90a9707 Details

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 the reach of children.

If swallowed, get 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 barbadensis leaf juice, fragrance, methylparaben, tocopheryl acetate, tetrasodium EDTA, disodium cocoamphodiacetate, butylparaben, citric acid, ethylparaben, propylparaben

Package Labeling:(23957-085-00)

Package Labeling:(23957-085-01)

INGREDIENTS AND APPEARANCE

SAFE AND SOFT ANTIBACTERIAL HAND WIPES 15 COUNT

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23957-085
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:23957-085-00	15 in 1 CARTON	06/01/2020
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:23957-085-01	25 in 1 CARTON	06/01/2020
2		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020

Labeler - Albaad USA, Inc (143406457)

Revised: 4/2020

Document Id: a2394251-a24d-d2c0-e053-2995a90a681c

Set id: a2394351-e2a2-0106-e053-2995a90a9707

Version: 1

Effective Time: 20200401