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NDC 54860-0401-01 Hand sanitizer 29ml 65 mL/100mL Details

Hand sanitizer 29ml 65 mL/100mL

Hand sanitizer 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	54860-0401
Product ID	54860-401_eb5d6739-ee37-cd74-e053-2a95a90ab659
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	Hand sanitizer 29ml
Proprietary Name Suffix	1
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	65
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 54860-0401-01 (54860040101)

Pricing Information	N/A
NDC Package Code	54860-401-01
Billing NDC	54860040101
Package	29 mL in 1 BOTTLE, PLASTIC (54860-401-01)
Marketing Start Date	2022-10-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb5d6739-ee36-cd74-e053-2a95a90ab659 Details

Drug Facts

Medical Ingredient

Ethyl Alcohol 65% purpose：Antiseptic

keep out of reach of children

In case of accidental ingestion.

seek professional assistance or contact a Poison Control Center immediately.

Recommended for repeated use.

use anywhere without water.

Warning

For external use only.

Flammable,Keep away from heat or flame.

Discontinue use if skin becomes irritated and ask a doctor before continuing use.

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

Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum, sodium hydroxide, CI 19140, CI 42090, CI 14700

Directions

Wet hands thoroughly with product and rub until dry without wiping.

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.

When using this product

Keep out of the eyes. In case of contact with eyes. flush thoroughly with water.

Do not inhale or ingest.

Avoid contact with broken skin

Purpose

Antiseptic

Stop use and ask a doctor

if irritation or rash occurs,these may be signs of a serious condition.

Use

Anti-bacterial Hand Gel is gentle yet effective to decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Use anywhere without water.

Other information

Do not store above 105 F.

May discolor some fabrics.

Harmful to wood finishes and plastics.

Do not use

in children less than 2 months of age

on open skin wounds.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 29ML 01

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.08 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL in 100 mL
POMEGRANATE (UNII: 56687D1Z4D)	0.2 mL in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.25 mL in 100 mL
WATER (UNII: 059QF0KO0R)	34.3696 mL in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0001 mL in 100 mL
D&C YELLOW NO. 11 (UNII: 44F3HYL954)	0.0001 mL in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0001 mL in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0001 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-401-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/19/2022

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(54860-401)

Revised: 10/2022

Document Id: eb5d6739-ee37-cd74-e053-2a95a90ab659

Set id: eb5d6739-ee36-cd74-e053-2a95a90ab659

Version: 1

Effective Time: 20221019

Search by Drug Name or NDC

NDC 54860-0401-01 Hand sanitizer 29ml 65 mL/100mL Details

Hand sanitizer 29ml 65 mL/100mL

Product Information

Package

Package Images

NDC 54860-0401-01 (54860040101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL eb5d6739-ee36-cd74-e053-2a95a90ab659 Details

Drug Facts

Medical Ingredient

keep out of reach of children

Warning

Inactive ingredients

Directions

Other information

When using this product

Purpose

Stop use and ask a doctor

Use

Other information

Do not use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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