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NDC 54860-0392-01 Mellow 59ml instant hand sanitizer 62 mL/100mL Details

Mellow 59ml instant hand sanitizer 62 mL/100mL

Mellow 59ml instant hand sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Shenzhen Lantern Science Co.,Ltd. The primary component is ALCOHOL.

Product Information

NDC	54860-0392
Product ID	54860-392_dc6c7c38-6283-e15c-e053-2995a90a4bf4
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	Mellow 59ml instant hand sanitizer
Proprietary Name Suffix	1
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Shenzhen Lantern Science Co.,Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 54860-0392-01 (54860039201)

Pricing Information	N/A
NDC Package Code	54860-392-01
Billing NDC	54860039201
Package	59 mL in 1 BOTTLE, PLASTIC (54860-392-01)
Marketing Start Date	2022-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dc6c7c74-4b2a-8878-e053-2995a90ac2da Details

Drug Facts

Medicical Ingredient

Medicical Ingredient Purpose

Ethyl Alcohol 62% Antiseptic

Features

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

use anywhere without water.

Warning

For external use only.

Flammable, keep away from heat and flame.

Discontinue if skin becomes irritated and ask a doctor .

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.

Non-Medicinal

Alcohol，Aqua(water)，Isopropyl Alcohol，Glycerin，Carbomer，Aminomethyl Propanol，Parfum，Propylene Glycol，ISOPROPYL MYRISTATE，ALOE BARBADENSIS LEAF JUICE，Tocopheryl Acetate，YELLOW 5，BLUE 1

Directions

Wet hands thoroughly with product and rub until dry without wiping

For children under 6, use only under adult supervision.

Not recommended for infants.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Do not inhale or ingest.

Avoid contact with broken skin.

Other information

Do not store above 105F.

May discolor some fabrics.

Harmful to wood finishes and plastics.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELLOW 59ML INSTANT HAND SANITIZER 01

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-392
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL in 100 mL
ALOE (UNII: V5VD430YW9)	0.15 mL in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.001 mL in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.00006 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.26 mL in 100 mL
WATER (UNII: 059QF0KO0R)	36.307916 mL in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	0.5 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.08 mL in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.000024 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 mL in 100 mL

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-392-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/11/2022

Labeler - Shenzhen Lantern Science Co.,Ltd (421222423)

Registrant - LANTERN HEALTH&BEAUTY LAB INC (086860340)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co.,Ltd.		421222423	manufacture(54860-392)

Revised: 4/2022

Document Id: dc6c7c38-6283-e15c-e053-2995a90a4bf4

Set id: dc6c7c74-4b2a-8878-e053-2995a90ac2da

Version: 4

Effective Time: 20220411