WECLEAN ANTIBACTERIAL HAND SANITIZER TEA TREE SCENT- ethyl alcohol gel 
Landy International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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51706-918 WeClean Antibacterial Hand Sanitizer Tea Tree Scent Ethyl Alcohol(62%)

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.

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

Arlats(0-3O0 alyl acylate csspolymer, Ascorbyl pamitat, Clulose,
Fragrance (arum), Gyverin, Hydroxyprop mltlulose, Jojoba Esters,
Lactose, Limonene, Lnalool, Tocophery| acetate, Tieanolamine,
Utrarine(l 7007 Water(Aqua).

Package Label - Principal Display Panel

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WECLEAN ANTIBACTERIAL HAND SANITIZER TEA TREE SCENT 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-918
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-918-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
2NDC:51706-918-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
3NDC:51706-918-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2020
Labeler - Landy International (545291775)
Registrant - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Wecool Toys080480202label(51706-918)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-918)

Revised: 3/2022
Document Id: dab93dd4-65b3-a848-e053-2995a90a13cd
Set id: abee9310-87e4-3c0f-e053-2a95a90ac33a
Version: 3
Effective Time: 20220321
 
Landy International