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NDC 54860-0393-01 Mellow hand sanitizer 236ml ML312 75 mL/100mL Details

Mellow hand sanitizer 236ml ML312 75 mL/100mL

Mellow hand sanitizer 236ml ML312 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	54860-0393
Product ID	54860-393_dce89693-bf17-52f6-e053-2995a90a08fa
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 236ml ML312
Proprietary Name Suffix	1
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	75
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 54860-0393-01 (54860039301)

Pricing Information	N/A
NDC Package Code	54860-393-01
Billing NDC	54860039301
Package	236 mL in 1 BOTTLE, PLASTIC (54860-393-01)
Marketing Start Date	2022-04-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dce88759-e718-7f93-e053-2a95a90a417e Details

Drug Facts

Active Ingredient

Active Ingredients Purpose

Ethyl Alcohol 62% Antiseptic

Feature

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Use anywhere without water.

Recommended for repeated use.

use anywhere without water.

Warning

For external use only:hands,avoid ayes ,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 accidenal ingestion.seek professional assistance or contact a poison control center immediately.

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.

Inactive ingredients

water，Isopropyl Alcohol，Glycerin，Carbomer，Aminomethyl Propanol，Parfum，Propylene Glycol，ISOPROPYL MYRISTATE，ALOE BARBADENSIS LEAF JUICE，Tocopheryl Acetate，FD&C Yellow No.5(Tartrazine),FD&C Blue No.1.

Directions

wet hands thoroughyly 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.

SPL UNCLASSIFIED SECTION

Do not store above100℉（38℃）

May discolor some fabrics.

Harmful to wood finishes and plastics.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELLOW HAND SANITIZER 236ML ML312 01

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-393
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
ALOE (UNII: V5VD430YW9)	0.2 mL in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.001 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.4 mL in 100 mL
WATER (UNII: 059QF0KO0R)	23.057972 mL in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	0.5 mL in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.00002 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.14 mL in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.000008 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 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:54860-393-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/18/2022

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(54860-393)

Revised: 4/2022

Document Id: dce89693-bf17-52f6-e053-2995a90a08fa

Set id: dce88759-e718-7f93-e053-2a95a90a417e

Version: 17

Effective Time: 20220418

Search by Drug Name or NDC

NDC 54860-0393-01 Mellow hand sanitizer 236ml ML312 75 mL/100mL Details

Mellow hand sanitizer 236ml ML312 75 mL/100mL

Product Information

Package

Package Images

NDC 54860-0393-01 (54860039301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dce88759-e718-7f93-e053-2a95a90a417e Details

Drug Facts

Active Ingredient

Feature

Warning

Inactive ingredients

Directions

Other information

SPL UNCLASSIFIED SECTION

When using this product

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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