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NDC 51706-0903-01 Hand Sanitizer 62 mL/100mL Details

Hand Sanitizer 62 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	51706-0903
Product ID	51706-903_dabb9e08-1152-52f4-e053-2a95a90a3290
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	62
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 51706-0903-01 (51706090301)

Pricing Information	N/A
NDC Package Code	51706-903-01
Billing NDC	51706090301
Package	355 mL in 1 BOTTLE (51706-903-01)
Marketing Start Date	2020-05-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6469b6c-a141-4bd3-e053-2995a90a8a20 Details

Active Ingredient(s)

EthyI Alcohol 62%

Purpose

Antiseptic

Use

■decreases bacteria on the skin that could cause disease

■recommended for repeated use

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

When using this product■keep out of eyes. In case of contact with

eyes flush thoroughly with water.■avoid contact with broken skin■do not

inhale or ingest

Stop use and ask doctor if■irrtation and redness develop m condition

persists for more than 72 hours

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact

a poison control center right away.

Directions

■wet hands thoroughly with product and allow to dry

without wiping■for children under 6, use only under adult supervision

I not recommended for infants

Inactive ingredients

Inactive Ingredients Water(Aqua), AcrlatesC10-30 alky-

acrylate crosspolymer, Glycerin, Triethanolamine, Fragrance (Parfum),

Tocophery| acetate, Aloe barbadensis leaf extract, Denatonium Benzoate,

Phenoxyethanol, Etyhexylglycerin, Yellow 5(CI 19140),

Blue 1(CI 42090).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51706-903-01	355 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(51706-903)

Revised: 3/2022

Document Id: dabb9e08-1152-52f4-e053-2a95a90a3290

Set id: a6469b6c-a141-4bd3-e053-2995a90a8a20

Version: 3

Effective Time: 20220321