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NDC 54860-0398-01 Mellow hand sanitizer with aloe and vitamin E 29mL 75 mL/100mL Details

Mellow hand sanitizer with aloe and vitamin E 29mL 75 mL/100mL

Mellow hand sanitizer with aloe and vitamin E 29mL is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Shenzhen Lantern Scicence Co Ltd. The primary component is ALCOHOL.

Product Information

NDC	54860-0398
Product ID	54860-398_e5508b4a-c520-c5c5-e053-2a95a90a0d11
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 hand sanitizer with aloe and vitamin E 29mL
Proprietary Name Suffix	n/a
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Shenzhen Lantern Scicence 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 54860-0398-01 (54860039801)

Pricing Information	N/A
NDC Package Code	54860-398-01
Billing NDC	54860039801
Package	29 mL in 1 TUBE (54860-398-01)
Marketing Start Date	2022-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e5508b3d-bb1d-2d62-e053-2a95a90a9df1 Details

Drug Facts

Medicical Ingredient

Medicical Ingredient Purpose

Ethyl Alcohol 75%（V/V） 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-hands.avoid eyes,in case of eye contact,flush with water

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 Poison Control.

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 HAND SANITIZER WITH ALOE AND VITAMIN E 29ML

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-398
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL in 100 mL
PIGMENT BLUE 1 (UNII: 4SBE571RQF)	0.000008 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 mL in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.001 mL in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	0.5 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL in 100 mL
ALOE (UNII: V5VD430YW9)	0.2 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.14 mL in 100 mL
WATER (UNII: 059QF0KO0R)	23.457972 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
BASIC YELLOW 5 (UNII: 07BP340B4T)	0.00002 mL in 100 mL

Product Characteristics
Color	green (transparant)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-398-01	29 mL in 1 TUBE; Type 0: Not a Combination Product	08/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/08/2022

Labeler - Shenzhen Lantern Scicence Co Ltd (421222423)

Registrant - LANTERN HEALTH&BEAUTY LAB INC (086860340)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co.,Ltd.		421222423	manufacture(54860-398)

Revised: 8/2022

Document Id: e5508b4a-c520-c5c5-e053-2a95a90a0d11

Set id: e5508b3d-bb1d-2d62-e053-2a95a90a9df1

Version: 8

Effective Time: 20220803