ADVANCED FIRST HAND SANITIZER- hand sanitizer gel 
SYNERGYPLANETS 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.

----------

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use

Warnings

For external use only. Flammable. Keep away from heat or flame.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of 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

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

Qusetions?

1.310.635.7007

Package Label - Principal Display Panel

500mL Label (ADVANCED)

ADVANCED FIRST HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75484-002
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
TROLAMINE (UNII: 9O3K93S3TK)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75484-002-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - SYNERGYPLANETS INC. (695720324)
Registrant - SYNERGYPLANETS INC. (695720324)
Establishment
NameAddressID/FEIBusiness Operations
Farmer's grain korea694439983manufacture(75484-002)
Establishment
NameAddressID/FEIBusiness Operations
ICOMAX Co., Ltd.694834031manufacture(75484-002)

Revised: 5/2020
Document Id: a6aecbe6-1a6d-f3e8-e053-2a95a90abc11
Set id: a33b3296-9dac-bd1e-e053-2a95a90adaa8
Version: 3
Effective Time: 20200528
 
SYNERGYPLANETS INC.