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NDC 70108-0067-01 Smart Care Marvel Hand Sanitizer 62 mL/100mL Details

Smart Care Marvel Hand Sanitizer 62 mL/100mL

Smart Care Marvel 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	70108-0067
Product ID	70108-067_90a78b50-7d68-441b-a7a4-76eb362c602a
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 Marvel 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	62
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 70108-0067-01 (70108006701)

Pricing Information	N/A
NDC Package Code	70108-067-01
Billing NDC	70108006701
Package	29 mL in 1 BOTTLE (70108-067-01)
Marketing Start Date	2020-08-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a8144c7-8d29-44ed-a6cb-5ff3b159c722 Details

Drug Facts

Active ingredients

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

• To help reduce bacteria and germs on the skin.

Warnings

For external use only. Flammable.

• Keep away from fire or flame.

When using this product

• Keep out of eyes.

• Do not inhale or ingest.

• In case of contact with eyes, flush thoroughly with water.

• Avoid contact with broken skin.

Keep out of reach of children.

• In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 & plastics.

Inactive ingredients:

Water, Carbomer, Fragrance, Aminomethyl Propanol, Denatonium Benzoate, *Blue 1(CI 42090), *Red 4(CI 14700), *Red 33(CI 17200), *Yellow

5(CI 19140). *Contains one or more of these ingredients.

Questions?

(909)434-0911

SPL UNCLASSIFIED SECTION

KILLS 99% OF MOST COMMON GERMS

DESIGNED IN U.S.A.

MADE IN CHINA

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY

ASHTEL STUDIOS INC.

ONTARIO, CA 91761

Smart Care*

SMARTCAREUS.COM

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE MARVEL HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70108-067
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70108-067-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/20/2020

Labeler - Ashtel Studios, Inc (148689180)

Revised: 8/2020

Document Id: 90a78b50-7d68-441b-a7a4-76eb362c602a

Set id: 1a8144c7-8d29-44ed-a6cb-5ff3b159c722

Version: 1

Effective Time: 20200824