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 DENAT. 62% w/w

INACTIVE INGREDIENT

Water, Glycerin, Carbomer, Triethanolamine, Hydroxyacetophenone, Fragrance, Ethylhexylglycerin, Trehalose, Hamamelis Virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Water, 1,2-Hexanediol, Sodium Hyaluronate, Linalool, Hexyl Cinnamal

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:59078-807
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
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Trehalose (UNII: B8WCK70T7I)  
WITCH HAZEL (UNII: 101I4J0U34)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-807-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2020
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
MEGACOS MANUFACTURING Co., Ltd.694745986manufacture(59078-807)

Revised: 7/2020
Document Id: fda8151c-75ca-4087-aee8-1396132cea5c
Set id: 5c55b652-0baa-4469-bdbd-1b688ab49bba
Version: 2
Effective Time: 20200721
 
TONYMOLY CO., LTD.