HAND SANITIZER- alcohol gel 
Lollicup USA Inc

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 70% v/v

Purpose

Antiseptic

Uses

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 heat or flame

Do not use

in children less than 2 months of age. on open skin wounds

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 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.

Directions

Other information

Inactive ingredients

Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

image of bottle label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78782-016
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
LEMON OIL (UNII: I9GRO824LL)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78782-016-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/08/2020
Labeler - Lollicup USA Inc (009713582)

Revised: 6/2020
Document Id: a78f68ce-e729-6f28-e053-2995a90a5bc0
Set id: a78f475a-fa17-713f-e053-2995a90ac452
Version: 1
Effective Time: 20200608
 
Lollicup USA Inc