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NDC 54860-0397-01 HARBOR FREIGHT Hand sanitizer 59mL 70 mL/100mL Details

HARBOR FREIGHT Hand sanitizer 59mL 70 mL/100mL

HARBOR FREIGHT Hand sanitizer 59mL is a TOPICAL GEL 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	54860-0397
Product ID	54860-397_e4c0885b-2050-60ce-e053-2995a90aa165
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	HARBOR FREIGHT Hand sanitizer 59mL
Proprietary Name Suffix	1
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
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 54860-0397-01 (54860039701)

Pricing Information	N/A
NDC Package Code	54860-397-01
Billing NDC	54860039701
Package	59 mL in 1 BOTTLE, PLASTIC (54860-397-01)
Marketing Start Date	2022-07-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e4c092e9-7e92-4a56-e053-2995a90a7b31 Details

Drug Facts

Active Ingredient

Active Ingredients Purpose

Ethyl Alcohol 70% Antiseptic

Use

the hand sanitizer to help reduce bacteria that potentially can cause disease,For use when soap and water are not available.

Recommended for repeated use.

use anywhere without water.

Warning

For external use only,Flammable,keep away from heat or flame.

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,Glycerin,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Parfum,Aloe Yohjyu Matsu Ekisu,Tocopheryl Acetate.

Directions

place enough product on hands to cover all surfaces.rub hands together until dry.

supervise children under 6 years of age when using this product to avoid swallowing.

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 eyes,ears,and mouth.In case of contact with eyes,rinse eyes thotoughly with water.

SPL UNCLASSIFIED SECTION

Store between 15-30℃（59-86F）

Avoid freezing and excessive heat above 40℃（104F）

DO NOT USE

in children less than 2 months of age

on open skin wounds

Stop use and ask a doctor

If irritation or rash occurs,these maybe signs of a serious condition.

Keep out of reach of children

If swallowed,get medical help or contact a Poison control center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARBOR FREIGHT HAND SANITIZER 59ML 01

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-397
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL in 100 mL
ALOE (UNII: V5VD430YW9)	0.05 mL in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.3 mL in 100 mL
WATER (UNII: 059QF0KO0R)	28.949 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-397-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/27/2022

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

Revised: 7/2022

Document Id: e4c0885b-2050-60ce-e053-2995a90aa165

Set id: e4c092e9-7e92-4a56-e053-2995a90a7b31

Version: 1

Effective Time: 20220726

Search by Drug Name or NDC

NDC 54860-0397-01 HARBOR FREIGHT Hand sanitizer 59mL 70 mL/100mL Details

HARBOR FREIGHT Hand sanitizer 59mL 70 mL/100mL

Product Information

Package

Package Images

NDC 54860-0397-01 (54860039701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e4c092e9-7e92-4a56-e053-2995a90a7b31 Details

Drug Facts

Active Ingredient

Use

Warning

Inactive ingredients

Directions

Other information

When using this product

SPL UNCLASSIFIED SECTION

DO NOT USE

Stop use and ask a doctor

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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