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NDC 51706-0901-03 Hand Sanitizer 75 mL/100mL Details

Hand Sanitizer 75 mL/100mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Landy International. The primary component is ALCOHOL.

Product Information

NDC	51706-0901
Product ID	51706-901_dabbac64-0107-738f-e053-2a95a90a9dd6
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
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	Landy International
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51706-0901-03 (51706090103)

Pricing Information	N/A
NDC Package Code	51706-901-03
Billing NDC	51706090103
Package	500 mL in 1 BOTTLE (51706-901-03)
Marketing Start Date	2020-05-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a645ea31-b754-24f8-e053-2a95a90a89b0 Details

Active Ingredient(s)

Alcohol Denat. 75%

Purpose

Antimicrobial

Use

Hand Cleansing Gel to help reduce bacteria on the skin.

Warnings

For extemal use only.● Flammable. Keep away from heat or flame.

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse

eyes thoroughly with water.

Stop use and ask a doctor

If rritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dispense a small amount onto dry hands and

massage well into skin.●Do not rinse.

Inactive ingredients

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glycerin.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-901
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-901-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020
2	NDC:51706-901-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020
3	NDC:51706-901-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/27/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-901)

Revised: 3/2022

Document Id: dabbac64-0107-738f-e053-2a95a90a9dd6

Set id: a645ea31-b754-24f8-e053-2a95a90a89b0

Version: 4

Effective Time: 20220321