LAB AMAROS CAMELLIA SANITIZER- ethanol gel 
AMAROS 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

Ethanol 62.0% v/v

INACTIVE INGREDIENTS

Water, Propylene Glycol, Glycerin, Dimethicone, Carbomer, Triethanolamine, Tocopheryl Acetate, Menthol

PURPOSE

SANITIZER

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

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

Uses

■ Hand sanitizer to decrease the bacteria on the skin.
■ Recommended for repeated use.

Directions

■ Take an appropriate amount on your hands and rub thoroughly to dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

LAB AMAROS CAMELLIA SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60899-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL310 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Menthol (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60899-120-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2021
Labeler - AMAROS CO., LTD. (690338801)
Registrant - AMAROS CO., LTD. (690338801)
Establishment
NameAddressID/FEIBusiness Operations
AMAROS CO., LTD.690338801manufacture(60899-120)

Revised: 5/2021
Document Id: 9479a37d-426d-4c8c-bea9-6c6a2934f0f7
Set id: 40822b24-0cfd-4fe6-88c7-9e195e9921b1
Version: 1
Effective Time: 20210528
 
AMAROS CO., LTD.