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NDC 70108-0070-01 Smart Care Advanced Hand Sanitizer 70 mL/100mL Details

Smart Care Advanced Hand Sanitizer 70 mL/100mL

Smart Care Advanced Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Ashtel Studios, Inc. The primary component is ALCOHOL.

Product Information

NDC	70108-0070
Product ID	70108-070_c9297af4-e822-4c78-9df9-2c9f8f0c219c
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 Advanced Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
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 70108-0070-01 (70108007001)

Pricing Information	N/A
NDC Package Code	70108-070-01
Billing NDC	70108007001
Package	500 mL in 1 BOTTLE (70108-070-01)
Marketing Start Date	2021-01-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4cb83b05-1620-4bff-ac1e-37bfbb6b838e Details

Drug Facts

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use:

To help reduce bacteria and germs on the skin

Warnings:

For external use only: hands

Flammable, keep away from fire or flame

When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water • Avoid contact with broken skin • Do not inhale or ingest

Keep out of reach of children

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

Directions:

Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Other Information:

• Do not store above 100°F(38°C) • May discolor some fabrics • Harmful to wood finishes and plastics

Inactive Ingredients:

Water (Aqua), Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF MOST COMMON GERMS

ORIGINAL WITH ALOE VERA

SPRING WATER

SWEET PEA

SMARTCAREUS.COM

QUESTIONS OR COMMENTS?

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

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

DESIGNED IN U.S.A. • MADE IN CHINA

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE ADVANCED HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70108-070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70108-070-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/12/2021

Labeler - Ashtel Studios, Inc (148689180)

Revised: 1/2021

Document Id: c9297af4-e822-4c78-9df9-2c9f8f0c219c

Set id: 4cb83b05-1620-4bff-ac1e-37bfbb6b838e

Version: 1

Effective Time: 20210115