HAND SANITIZER- alcohol gel 
Weckerle Cosmetics LLC

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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HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Anti-microbial

Use

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Water , Glycerin, Propanediol, Panthenol, Aminomethyl Propanol, Carbomer, Fragrance, Carthamus Tinctorius (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Sodium Hyaluronate, Green 5, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

precos

HAND
SANITIZER
GEL

KILLS
99.9%
OF GERMS
& BACTERIA

WITH ALOE VERA
& PRO VITAMIN B5
TO MOISTURIZE

OCEAN

3.4 FL OZ / 100mL

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62516-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Propanediol (UNII: 5965N8W85T)  
Panthenol (UNII: WV9CM0O67Z)  
Aminomethylpropanol (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Safflower Oil (UNII: 65UEH262IS)  
Cucumber (UNII: YY7C30VXJT)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
D&C Green No. 5 (UNII: 8J6RDU8L9X)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62516-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A06/19/2020
Labeler - Weckerle Cosmetics LLC (152060273)
Establishment
NameAddressID/FEIBusiness Operations
Weckerle Cosmetics LLC152060273LABEL(62516-001) , MANUFACTURE(62516-001)

Revised: 7/2020
Document Id: 41383987-d195-4acf-80be-7458f6ef1500
Set id: 37729c44-c53a-428b-bf9e-f4cc3f888a62
Version: 1
Effective Time: 20200713
 
Weckerle Cosmetics LLC