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NDC 70108-0071-01 Smart Care Antibacterial HANDSOAP 0.1809 g/100mL Details

Smart Care Antibacterial HANDSOAP 0.1809 g/100mL

Smart Care Antibacterial HANDSOAP is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Ashtel Studios, Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	70108-0071
Product ID	70108-071_f494e741-4f9f-4b5b-84a3-23820187109e
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 Antibacterial HANDSOAP
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.1809
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	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70108-0071-01 (70108007101)

Pricing Information	N/A
NDC Package Code	70108-071-01
Billing NDC	70108007101
Package	400 mL in 1 BOTTLE, PUMP (70108-071-01)
Marketing Start Date	2021-01-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 878e48b9-b54f-4694-be7a-fc7548fcad2f Details

Drug Facts

Active ingredient

Benzalkonium chloride 0.2% w/w

Purpose

Antiseptic

Use

For washing hands to decrease bacteria on hands

Warnings

For external use only

Do not use • on open skin wounds

When using this product • avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if • irritation and redness develop

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

Directions

Pump onto wet hands, vigorously work into a lather, and rinse thoroughly

Other information

Store in a cool dry place below 104°F

Inactive ingredients

water, cocamidopropyl betaine, cocamidopropylamine oxide, lauryl glucoside, cocamide DEA, glycerin, PEG-150 distearate, fragrance, disodium EDTA, benzophenone-4, citric acid, sodium chloride, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD&C blue no. 1, FD&C yellow no. 5, FD&C yellow no. 6, ext. D&C violet no. 2, FD&C red no. 40

Questions or Comments?

1-877-274-8358 Toll Free in USA • 1-909-434-0911 International

SPL UNCLASSIFIED SECTION

KILLS UP TO 99% OF MOST COMMON GERMS

CUCUMBER & TEA

LAVENDER

TROPICAL BEACH

SWEET PEACH

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DESIGNED IN USA • MADE IN CHINA

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE ANTIBACTERIAL HANDSOAP

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70108-071
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1809 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70108-071-01	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/13/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/13/2021

Labeler - Ashtel Studios, Inc (148689180)

Revised: 1/2021

Document Id: f494e741-4f9f-4b5b-84a3-23820187109e

Set id: 878e48b9-b54f-4694-be7a-fc7548fcad2f

Version: 1

Effective Time: 20210118