HAND SANITIZER PREMIUM FORMULA- hand sanitizer gel 
LTP Global

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

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

When using this product

Stop use and ask a doctor if

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, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

Package Label - Principal Display Panel

POUCH LABELOut Box Label

HAND SANITIZER PREMIUM FORMULA 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73812-002
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73812-002-05100 in 1 BOX06/22/2020
1NDC:73812-002-022 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2020
Labeler - LTP Global (694215916)
Establishment
NameAddressID/FEIBusiness Operations
ICOMAX Co., Ltd.694834031manufacture(73812-002)

Revised: 6/2020
Document Id: a8a55204-6901-3164-e053-2a95a90a94d5
Set id: a8a548c0-ac25-430f-e053-2995a90a0400
Version: 1
Effective Time: 20200622
 
LTP Global