FROZEN FRESH SCENTED HAND SANITIZER- alcohol gel 
Ouya Cosmetics Co., Ltd of Yiwu City

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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Frozen Fresh Scented Hand Sanitizer

Questions or Comments?

Call 1-888-893-0993

Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire and flames.

Do not use

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

Irritation and redness develop. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate.

Package Label - Principal Display Panel

Label

FROZEN FRESH SCENTED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54699-016
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54699-016-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2021
Labeler - Ouya Cosmetics Co., Ltd of Yiwu City (546464926)

Revised: 6/2021
Document Id: c45b7a29-e34d-7793-e053-2995a90ad480
Set id: c45b7e8f-47e1-5a86-e053-2a95a90a7b5b
Version: 1
Effective Time: 20210609
 
Ouya Cosmetics Co., Ltd of Yiwu City