ALOE HAND SANITIZER- alcohol gel 
TONYMOLY CO., LTD.

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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ACTIVE INGREDIENT

ALCOHOL 62% w/w

INACTIVE INGREDIENT

Water, Glycerin, Carbomer, Triethanolamine, Fragrance, Linalool, Hexyl Cinnamal, Aloe Vera Gel, Witch Hazel Extract, Butylphenyl Methylpropional, Trehalose Hydrate, Sodium Hyaluronate

PURPOSE

Antimicrobial

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. 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.

Uses

Hand gel that kills germs that can potentially cause disease.

Directions

Dispense an appropriate product onto the palm of hands. Rub hands together until dry.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

ALOE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-810
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
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WITCH HAZEL (UNII: 101I4J0U34)  
Butylphenyl Methylpropional (UNII: T7540GJV69)  
Trehalose (UNII: B8WCK70T7I)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-810-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2021
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
MEGACOS MANUFACTURING Co., Ltd.694745986manufacture(59078-810)

Revised: 3/2021
Document Id: 3f83fa16-2e74-4c98-bbc3-df4aba259e3e
Set id: 452c94ce-6bce-4b32-a3fc-1453d1602816
Version: 1
Effective Time: 20210331
 
TONYMOLY CO., LTD.