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NDC 70108-0072-01 Smart Care Personal Safety Kit 0.13 g/100mL Details

Smart Care Personal Safety Kit 0.13 g/100mL

Smart Care Personal Safety Kit is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Ashtel Studios, Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	70108-0072
Product ID	70108-072_f008266f-c308-4e26-9db3-03c42b1a9075
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	Smart Care Personal Safety Kit
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Ashtel Studios, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70108-0072-01 (70108007201)

Pricing Information	N/A
NDC Package Code	70108-072-01
Billing NDC	70108007201
Package	3 PACKET in 1 BOX (70108-072-01) / 1 PACKAGE in 1 PACKET / 2.6 mL in 1 PACKAGE
Marketing Start Date	2021-06-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 43948eb2-d2dd-4b6e-b1ea-f198fef339d5 Details

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

•Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only

When using this product do not use in or near 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 appears on the skin.

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

Directions

•Wet hands thoroughly with product and allow to dry.

•Discard wipes in trash receptacle after use. Do not flush.

•Children under 6 years of age should be supervised by adult when applying this product.

Inactive ingredients

Aqua,Phenoxyethanol, Polyaminopropyl biguanide, Glycerin, Propylene Glycol, Benzalkonium Chloride,Ethylhexylglycerin

SPL UNCLASSIFIED SECTION

3x FACE MASKS

3-PLY

3x ANTIBACTERIAL WIPES

Kills Up To 99.9% Of Most Common Germs

3x PAIRS OF VINYL HAND GLOVES

Powder Free

Latex Free

Kit Includes

3 Face Masks • 3 Antibacterial Wipes • 6 Vinyl Hand Gloves

Face Mask Directions

Place mask over nose and mouth, and place an ear loop around each ear. Pull bottom of mask under chin and mold the nose piece around the nose. The mask should cover face from the nose to underneath the chin. Discard mask after use. One size fits all.

Face Mask Warning

This mask is not a respirator. This product is intended for general purpose infection control practices. When properly worn, masks offer some protection to you, but does not eliminate the risk of contracting any disease or infection. Change mask immediately if splashed with blood or bodily fluids.

Gloves

Storage: Protect from freezing. Avoid excessive heat. Keep dry. Products should be shielded from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. Disposal: Dispose of gloves and all biologically contaminated matter in an appropriate container.

Wipes Warning

This wipe is for external use, not for internal use. Please keep away from children.

MEDICAL USE PROHIBITED

THIS PRODUCT IS A NON-MEDICAL DEVICE FOR CIVIL USE ONLY.

Smart Care®

SMARTCAREUS.COM

Designed in USA • Made in China

QUESTIONS OR COMMENTS?

1-877-274-8358 TOLL FREE IN U.S.A.

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS, AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE PERSONAL SAFETY KIT

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70108-072
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70108-072-01	3 in 1 BOX	06/03/2021
1		1 in 1 PACKET
1		2.6 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/03/2021

Labeler - Ashtel Studios, Inc (148689180)

Revised: 6/2021

Document Id: f008266f-c308-4e26-9db3-03c42b1a9075

Set id: 43948eb2-d2dd-4b6e-b1ea-f198fef339d5

Version: 1

Effective Time: 20210608