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NDC 51706-0957-01 WeClean Hand Sanitizer Orange Apple Scent 62 mL/100mL Details

WeClean Hand Sanitizer Orange Apple Scent 62 mL/100mL

WeClean Hand Sanitizer Orange Apple Scent 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	51706-0957
Product ID	51706-957_dab5f94d-4bf2-2a8c-e053-2995a90a2914
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	WeClean Hand Sanitizer Orange Apple Scent
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl 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	2023-12-31

Package

Package Images

NDC 51706-0957-01 (51706095701)

Pricing Information	N/A
NDC Package Code	51706-957-01
Billing NDC	51706095701
Package	250 mL in 1 BOTTLE (51706-957-01)
Marketing Start Date	2020-09-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b005d7b3-bce9-9b15-e053-2a95a90aa01e Details

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

helps eliminate bacteria on hands

Warnings

For external use only.

Flammable, Keep away from heat or flame,

Do not use

On children less than 2 months of age. on open skin wounds

When using this product keep out of eyes, ear, and mouth.

In case of contact with eve, rinse eyes thouroughly with water

Stop use and ask a doctor if irritation or rash occurs,

These may be a sign of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. except under adult supervision.

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

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.

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer,Ascorbyl palmitate,Cellulose,

Fragrance/Parfum, Glycerin, Hydroxypropyl methylcellulose,Jojoba Esters,

Lactose,Red 4(Cl14700), Tocopheryl acetate,Triethanolamine,Water(Eau).

Yellow 5(C119140).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

WECLEAN HAND SANITIZER ORANGE APPLE SCENT

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-957
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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TROLAMINE (UNII: 9O3K93S3TK)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51706-957-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/22/2020

Labeler - Landy International (545291775)

Registrant - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Wecool Toys		080480202	label(51706-957)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-957)

Revised: 3/2022

Document Id: dab5f94d-4bf2-2a8c-e053-2995a90a2914

Set id: b005d7b3-bce9-9b15-e053-2a95a90aa01e

Version: 2

Effective Time: 20220321